SI-BONE, Inc. Announces Published Guidance Recommendation for Minimally Invasive SI Joint Fusion from NICE

SAN JOSE, Calif., April 7, 2017 — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the U.K.’s National Institute for Health and Care Excellence (NICE) has published their Interventional Procedure Guidance document for minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain.1 The guidance recommends that MIS SI joint fusion be available to properly diagnosed patients in the U.K. National Health System (NHS).

NICE develops guidance and quality standards in health and social care and is a worldwide leader in technology evaluations. NICE’s role is to improve outcomes for people using the NHS and other public health services.2

The recommendation states that the safety and efficacy of minimally invasive sacroiliac (SI) joint fusion surgery, based primarily on the strong clinical evidence from the iFuse Implant, is adequate provided that standard arrangements are in place.  They also recommend that the procedure be performed by trained surgeons using a lateral transarticular approach, and that patients have been properly diagnosed with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruption.

Use with standard arrangements is the most positive recommendation that NICE can make for an interventional procedure such as MIS SI joint fusion.  Standard arrangements means that there is enough high-quality clinical evidence to show that the procedure is effective and safe enough for doctors to consider as a treatment option for appropriate patients,” according to W. Carlton Reckling, MD, MBA, Chief Medical Officer and Vice President Medical Affairs at SI-BONE.

About SI-BONE, Inc.

SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion.  The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth3, facilitating long-term fusion of the joint.  The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials.  Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9868.040617

  1. Minimally invasive sacroiliac joint fusion surgery for chronic sacroiliac pain. NICE Interventional Procedures Guidance [IPG578]. April 2017. https://www.nice.org.uk/guidance/IPG578/chapter/1-recommendations

  2. https://www.nice.org.uk/Media/Default/About/Who-we-are/NICE_Charter.pdf

  3. MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

Medovex Corporation Partners with Technology Consult Berlin GmbH in Germany

ATLANTA, GA–(Marketwired – Apr 5, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it has entered into a partnership with TCB – Technology Consult Berlin GmbH for distribution of its Denervex™ system throughout Germany. TCB is expected to provide sales, marketing and distribution services.

TCB, is a associated partner of Kalms & Partner Consulting (http://www.kalmsconsult.com/) based in Berlin, Germany offers a complete consultancy service for medical device manufacturers and selected services for pharmaceutical companies. The company offers sales and marketing, full distribution services, strategic and operational support in the fields of market access, health economics, reimbursement and business development.

Manfred Sablowski, Senior Vice President Global Sales & Marketing of Medovex, stated, “TCB – Berlin in Germany serves as a perfect call point fit for our mission to provide a successful distribution, sales and marketing foundation for our entry and expansion of our footprint of the DenerveX System in the most important market in Europe.”

On March 13, 2017, the Company previously announced that the reimbursement authority in Germany had renewed reimbursement payment coding for the DenerveX System technology for the treatment of the Facet Joint Syndrome for 2017.

The renewed reimbursement coding, effective immediately, was released in the Diagnosis-Related Group (DRG) system in 2017 in Germany. This new coding allows for hospitals and outpatient centers to receive reimbursement for the use of the DenerveX System for the treatment of the Facet Joint Syndrome in the spine.

According to Dennis Moon, Executive Vice President of Medovex, “The renewal of the reimbursement code for 2017 in Germany will be a significant driver for our European launch preparation for the DenerveX System. We look forward to targeting the German market through our new relationship with TCB – Berlin as the country is often recognized as a leader in early clinical adoption of new and cost effective technologies, being on the forefront of establishing reimbursement guidelines. Reimbursement is perhaps the most foundational element supporting adoption for a medical technology.”

The Company’s patented DenerveX System, is not yet commercially available in the EU and the U.S. The DenereX System is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX Device Kit, containing a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.

DenerveX is not yet CE marked or FDA cleared.

About Medovex:
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward- looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

SPINEWAY : Signature of a distribution agreement in Australia 1st Mont-Blanc implants

  Ecully, 5 April 2017

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces the signature of a contract with an Australian distributor for the sale of its implants and instruments in Oceania.

The distribution agreement follows the approval of the Group’s flagship lines and reinforces Spineway’s international coverage.

The distributor, based in Sydney, specializes in orthopedics and is extremely experienced with the spine. It will sell Spineway’s Mont-Blanc, TwinPeaks, Kili, Ayers Rock and Blue Mountain lines. Its salesforce and distribution network will allow the Group to cover Sydney and Australia’s other major cities.

The first surgeries using Mont-Blanc implants have already taken place and were very successful.

Spineway thus establishes its know-how in overseas exports and should see its sales increase steadily in this new geographic area.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication:
2016 Annual Results – 26 April 2017, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – ALSPW     

Contacts:

Investor Relations
David Siegrist – Finance Director
Tel: +33 (0)4 72 77 01 52
finance.dsg@spineway.com
Financial Communication
Jérôme Gacoin / Solène Kennis
Tel: +33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/524d353f-a4b8-4e92-8c9f-23188e2e1812

SI-BONE, Inc. Announces 50th Peer-Reviewed Publication for the iFuse Implant System® and 25,000th iFuse Procedure

SAN JOSE, Calif., April 3, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that the highly respected journal Spine has published the 50th peer-reviewed iFuse paper titled Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Analysis1. Compared to analyses performed in individual trials, pooling data from these three trials allowed a more statistically powerful determination of patient factors that could predict clinical outcomes after either surgery or non-surgical treatment for appropriately diagnosed patients with SI joint dysfunction.

The pooled analysis study included 423 patients from the three combined multicenter prospective trials, two of which were randomized controlled trials, in which 97 patients received non-surgical management (“NSM”) and 326 patients received SI joint fusion with the iFuse Implant™ from 2013 to 2015. Overall, positive effectiveness, durability and opioid user reduction responses were much higher in the iFuse Implant group compared to the NSM group. In the NSM group, there were no predictors of improved outcomes. In contrast, in the iFuse Implant group, smoking and opioid use were predictive of somewhat smaller improvements in pain relief and disability whereas higher patient age and longer duration of pain were predictive of larger improvements. Although statistically significant, the difference in treatment responses in these groups were clinically unimportant; that is, all subgroups had clinically large improvements after SI joint fusion with iFuse Implants.

“These results indicate that SI joint fusion with triangular iFuse Implants leads to better treatment outcomes compared to non-surgical management and that the extent of improvement with SI joint fusion is only modestly associated with smoking, opioid use, patient age and duration of pain,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE and study co-author. “Some surgeons do not offer some treatments to smokers or opioid users; for SI joint fusion with iFuse Implants, however, smokers and opioid users had marked and clinically important responses.”

The company also announced that the iFuse Implant System has been used in more than 25,000 procedures worldwide and continues to be the Method of Choice for SI Joint FusionSM. Adoption of the iFuse Procedure™ has continued to grow as surgeons learn to include the SI joint as part of their routine low back pain diagnostic exam and insurance coverage for the procedure has expanded.  Recently, Healthcare Service Corporation (HCSC), the 4th largest commercial health plan in the U.S., established an exclusive coverage policy for iFuse for Blue Cross Blue Shield participants in Texas, Illinois, Montana, New Mexico and Oklahoma.

“These are two remarkable milestones that were made possible with over eight years of relentless dedication by our organization and thousands of health care providers who manage patients with SI joint disorders,” said Jeffrey Dunn, President and CEO of SI-BONE. “Together, we have raised awareness and educated thousands on SI joint diagnosis and treatment and with continued focus on education and clinical evidence, we are hopeful that all those suffering from chronic SI joint dysfunction who fail conservative care are able to obtain the appropriate therapy to help them.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth2, facilitating long-term fusion of the joint. The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9758.040317

  1. Dengler J, Duhon B, Whang P, Frank C, Glaser J, Sturesson B, Garfin S, Cher D, Rendahl A, Polly D, on behalf of the INSITE, iMIA, SIFI study groups. Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint: A Pooled Analysis. Spine. Published Ahead-of-Print March 27, 2017. doi:10.1097/BRS.0000000000002169
  2. MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

 

SOURCE SI-BONE, Inc.

Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team

WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team.  Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership.  Together, Mr. Lynch and Mr. Scott have over 40 years of relevant industry experience.

Mr. Lynch joins the company with over 22 years of medical device and 15 years of spine industry marketing experience having previously served as Vice President of Global Marketing at DFINE, VertiFlex, and Zimmer Spine.

Mr. Scott joins Providence following over 16 years at ArthroCare as Vice President of OUS Sports Medicine, Vice President of Asia Pacific Commercial Operations, and US Vice President ENT Sales at Smith & Nephew.

Providence also announced recent 510(k) clearances from the FDA for the standalone use of the CAVUX™ Cervical Cage-L System as well as approval for its ALLY™ Facet Screws.  These new clearances are complimentary to the company’s flagship DTRAX® Spinal System and are all provided terminally sterile for single-use to ensure efficiency and consistency.

Scott Lynch and Michael Scott are important additions to our Executive Management team at Providence.  Their veteran leadership and successful experience with high growth businesses make them an ideal fit for Providence at this exciting stage of our business,” said Jeff Smith, CEO of Providence Medical Technology.  “With these new 510(k) clearances, we are pleased to offer our surgeon customers stand-alone anterior stabilization and posterior non-segmental stabilization for their cervical fusions.”

The CAVUX™ Cervical Cage-L System is manufactured from medical grade titanium and available in a variety of sizes.  The implant offers proprietary grit-blasted and acid-etched surfaces, a large space for allogenic and autogenous bone graft and includes self-drilling and self-tapping screws for additional, standalone fixation.

The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.  The titanium implants are available in a variety of sizes to accommodate patient anatomy and are intended to provide mechanical support and stability until spinal fusion is achieved.

Providence Medical Technology’s family of products for cervical spinal fusion includes instruments, intervertebral cages, orthopedic bone screws, and allograft bone.  All products are provided sterile for single use only.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company developing innovative solutions addressing the $2 billion worldwide cervical spine market. The company’s focus is on commercializing the DTRAX® platform of single-use, tissue-sparing instruments and CAVUX™ and ALLY™ implants for cervical fusion, as well as other technologies that improve cervical spine procedures for both physicians and patients.

For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology, Inc.

NuVasive Receives First-Ever FDA Clearance For Cervical Interbody Implant System Used In More Than Two Levels

SAN DIEGO, March 29, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent® Small Interbody™ System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.

Cervical radiculopathy and myelopathy secondary to cervical degenerative discs are common diagnoses in adult patients and have been shown to cause significant disability and loss of productivity.1 As a result of this common condition, more than 200,000 cervical surgical procedures are performed in the U.S. per year.2

“This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market. The ability to treat multi-level cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons,” said Jason Hannon, NuVasive’s president and chief operating officer. “This first and only clearance is an example of NuVasive’s commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market.”

The NuVasive CoRoent Small Interbody System is an interbody cage manufactured from PEEK-Optima that provides stabilization of the spinal motion segment while fusion takes place. A hollow core allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy or tantalum.

The implants included in the CoRoent Small Interbody System clearance are CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic (SHL), and CoRoent Small Contoured (SC).

About NuVasive

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

Forward-Looking Statements

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

1Grasso G: Clinical and radiological features of hybrid surgery in multilevel cervical degenerative disease. Eur Spine J 2015;24(Suppl 7):S842-8.
2American Associated of Neurological Surgeons. Artificial cervical disc surgery. [AANS web site]. May 2016. Available at: http://www.aans.org/Patient%20Information/Conditions%20and%20Treatments/-Artificial%20Cervical%20Disc.aspx. Accessed March 27, 2017.

 

CONTACT: Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com, Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com

Medtronic, DePuy Synthes Lead Cervical and Lumbar Artificial Disc Market

BY MILITARY NEWS

VANCOUVER, BC–(Marketwired – March 28, 2017) – According to a new series of reports on the U.S. spinal implants and vertebral compression fracture market by iData Research (www.idataresearch.com), the motion preservation segment will be the fastest growing in the market fueled by the release of a vast array of new devices in already established markets, most notably the cervical (CAD) and lumbar artificial disc (LAD) markets. Procedure number growth, as well as favorable reimbursement policies is expected for these devices driven by positive clinical results involving novel and emerging technologies.

However, traditional fixation procedures will limit growth of the artificial disc market. The traditional cervical, thoracolumbar and interbody fixation and fusion markets are currently the gold standard for treatment of many indications that artificial discs address. These devices cost less than artificial discs, which can be a major preference factor for many doctors and patients.

“Traditional fusion markets are expected to show consistent growth rate but will eventually begin to stabilize in value over the next several years as motion preservation and minimally invasive surgery (MIS) procedures become increasingly common,” explains Dr. Kamran Zamanian, CEO of iData. “As the U.S. spinal implant market grows in size, more competitors will enter the markets as well as existing competitors broadening their portfolios with new products including motion preservation implants.”

 

READ THE REST HERE

Altus Spine announces Silverstone Titanium FDA 510(k) Clearance

West Chester PA, March 17, 2017 – Altus Spine, a leader in the development and innovation of medical devices used in spinal correction surgery, announces the FDA clearance of the Silverstone Titanium Interbody Fusion (IBF) System.  The Silverstone Titanium IBF System is designed to be implanted in the lumbar spine to aid in the stability and support of vertebral bodies during fusion.

The Silverstone Titanium IBF System is a simple, yet comprehensive, system that includes both PLIF and TLIF implants, and supporting instrumentation.  Introducing Altus Spine’s MicroLOC™ technology, the Silverstone Titanium IBF System incorporates the latest combination of macro- and micro-endplate surface texture design.  MicroLOC™ surface technology results in a proprietary, porous grip surface intended to provide an optimal environment for initial bone growth while minimizing the potential for implant migration.

“The development of MicroLOC™ surface technology was in response to surgeon requests for implant surfaces that encourage better on-growth of bone,” says Michael Fitzgerald, CEO and President of Altus Spine.  “The Silverstone Titanium implant is the first implant to employ MicroLOC™ surface technology.  The combination of easy implant insertion with the MicroLOC™ porous surface results in a state-of-the-art IBF implant.”

The Silverstone Titanium IBF System was created through the concentrated efforts of surgeons, engineers, and machinists to deliver the most advanced and cost effective implant system possible.  Its release closely follows last month’s market release of the Fuji Cervical Plate System.

Indications

The Altus Spine Titanium Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.  These patients should have had six months of non-operative treatment.  These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Titanium Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

Altus Spine

Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices.  Altus strives to improve patient care by designing and developing products to meet the highest standards in an ever changing and evolving field.  Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world.  For additional information, and to inquire about distribution opportunities , please visit www.altus-spine.com

Forward Looking Statements

All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions.  These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected.  These uncertain factors include, but are not limited to; acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases.  All risks and potential complications can be found in our most recent 510k report from the Food and Drug Administration (FDA).  Given the constantly changing market, readers are encouraged to not place undue reliance on forward looking statements.  Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.

Alphatec Completes its Senior Leadership Team with Appointment of Brian Snider, Executive Vice President, Strategic Marketing and Product Development

CARLSBAD, Calif., March 24, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today the addition of two new executives with proven track records in the spine industry, naming Brian Snider as Executive Vice President, Strategic Marketing and Product Development, and Chris Ryan as Area Vice President of Sales in the U.S. Central Region.  Drawing on their deep commercial spine experience, Mr. Snider and Mr. Ryan will focus on building brand awareness with surgeon customers and driving market demand for Alphatec’s differentiated product solutions.

Brian Snider Named EVP Strategic Marketing and Product Development

“I am pleased to welcome Brian to the Alphatec Senior Leadership Team,” said Terry Rich, Alphatec Spine’s Chief Executive Officer.  “Brian’s arrival completes our efforts over the past few months to restructure Alphatec leadership by adding individuals with significant spine and orthopedic experience. Brian brings an unquestioned track record of building strong surgeon relationships, product innovation, and commercialization, having brought to market over 30 innovative spine products and procedures.  We look forward to leveraging his energy and expertise, as we launch our new products, including Battalion™ Lateral and Arsenal™ Deformity, deepen our engagement with surgeons, and aggressively build our brand.  I look forward to partnering with Brian and believe his contributions will help take Alphatec to the next level of innovation and growth.”

As Alphatec’s Executive Vice President, Strategic Marketing and Product Development, Mr. Snider will lead all aspects of the Company’s go-to-market strategy, including product development, marketing, brand awareness and driving market adoption.

Mr. Snider has spent the past 11 years focused on marketing, brand and product development, and global product management in the spine and medical device industries.  Prior to joining Alphatec Spine, Mr. Snider spent nine years at NuVasive, Inc., where he most recently served as the Business Lead of Thoracolumbar Anterior, and had substantial responsibility over the anterior column business, including XLIF® and Anterior Column Realignment (ACR®).  Prior to NuVasive, Mr. Snider held marketing leadership roles at Alveolus, Inc., a medical device company focused on interventional stent technologies.  He started his career at KPMG consulting in various business units, including Life Sciences.

Mr. Snider holds an MBA from the Fuqua School of Business at Duke University and a Bachelor’s degree in Business Administration from The George Washington University.

Chris Ryan Named AVP Sales, Central Region

“I’m excited to bring Chris onboard as the first of our new regional area sales vice presidents,” said Mr. Rich.  “Given the recent launch of our three new products— Arsenal Deformity, Battalion Lateral and XYcor® Expandable Interbody—this is a perfect time for Chris to join the Alphatec team.  Chris brings a combination of high-performing sales leadership and distribution channel transformation experience that will be crucial to leading our sales agent relationships and accelerating our growth.  His reputation for high integrity, his deep understanding of the spine industry and his proven ability to drive significant revenue will make him an asset to our organization.”

As Alphatec’s Area Vice President, Sales, Central, Mr. Ryan will be responsible for expanding the Company’s presence in the Central United States, including building dedicated sales agent relationships, targeting new customer and market opportunities, as well as providing service and support for existing surgeon customers.

Mr. Ryan brings more than 20 years of progressive spine sales leadership experience to Alphatec.  Prior to joining Alphatec, Mr. Ryan held multiple sales leadership roles over a six-year period with Zimmer Biomet Spine, including as its Vice President of U.S. Sales and a member of the Zimmer Spine Leadership Team. Under Mr. Ryan’s leadership, Zimmer’s U.S. Spine Sales channel underwent a substantial, strategic change in distribution, yielding significant annual revenue growth.  Prior to Zimmer, Mr. Ryan served in a number of leadership capacities during his 14-year career at Medtronic, including Regional Vice President of Medtronic Spinal and Biologics business unit, responsible for Medtronic’s Central Region.

Mr. Ryan holds a Bachelor of Science in Economics from Western Michigan University.

Inducement Awards Granted

As an inducement to entering into employment with the Company and in accordance with NASDAQ Listing Rule 5635(c)(4) under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”), on March 16, 2017, the Compensation Committee of the Board of Directors approved the following inducement awards:

  • Mr. Snider: 75,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 75,000 shares of common stock.
  • Mr. Ryan: 25,000 restricted stock units (RSUs) (with the grant of such RSUs made subject to, and effective on, the date on which Alphatec files a Registration Statement on Form S-8 registering the shares of common stock issuable upon settlement of the RSUs, which filing is expected to occur later this month) and an option to purchase 25,000 shares of common stock.

The RSUs and stock options were granted pursuant to the Plan.  Collectively, the RSUs and options were granted as inducements material to the new employees entering into employment with Alphatec in accordance with NASDAQ Listing Rule 5635(c)(4).

The RSUs will vest in equal installments annually over four years on each of the first four anniversaries of the first date of employment, assuming in each case the employee 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 stock options will have an exercise price equal to the closing price per share of Alphatec’s common stock as reported by NASDAQ on the date of grant (March 20, 2017). The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, 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 delivering advancements in spinal fusion technologies. The Company markets 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 may contain “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. Alphatec Spine 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 Company’s ability to launch new products, deepen surgeon engagement, build brand awareness and accelerate growth. 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.  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 uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainty of success in launching new products and developing new products or products currently in the Company’s pipeline; the failure to achieve acceptance of the Company’s products by the surgeon community; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; the Company’s ability to compete with other competing products and with emerging new technologies; and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement.  Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine 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.

CONTACT: Investor/Media Contact:

Christine Zedelmayer 
Investor Relations 
Alphatec Spine, Inc. 
(760) 494-6610 
czedelmayer@alphatecspine.com

Global Spine Biologics Market Expected to Reach $2,214 Million by 2022 – Allied Market Research

PORTLAND, Oregon and PUNE, India, March 22, 2017 /PRNewswire/ —

Global spine biologics market was valued at $1,644 million in 2015, and is projected to reach $2,214 million by 2022, growing at a CAGR of 4.3% during the forecast period 2014-2022, according to a new report published by Allied Market Research.

Spine biologics are used during spine fusion surgery for the treatment of spinal deformities such as trauma, tumors, degenerative disc disease, and spinal cord injuries by stimulating bone growth formation through inflammatory stage, repair stage, and remodeling stage. Therefore, surge in the number of spinal fusion surgeries have fueled the adoption of biologics.

Get access to detailed report at: https://www.alliedmarketresearch.com/spine-biologics-market

The market is driven by factors such as increase in geriatric population and advantages of biologics such as minimal postoperative time, faster recovery, and ability to activate cellular growth. However, unfavorable reimbursement scenario, higher cost of bone grafts, and ethical issues related to bone grafting procedures hamper the market growth.

The bone graft substitutes segment generated the highest revenue in the global market, accounting for more than half of the total spine biologics market. In addition, the cell-based matrices segment is projected to grow rapidly, registering a CAGR of 5.9% during the forecast period.

According to Deepa Tatkare, Senior Analyst, Healthcare Research, Allied Market Research, “The emergence of biologic materials is one of the recent developments of spine fusion surgery. Earlier, autografts were considered as the ideal primary bone graft. However, allograft evolved as a better treatment option, owing to various associated complications such as pain, infection, and weakened bone. Thus, the use of biologics in spine surgeries is expected to witness higher demand in the future because of the constant development of new products.

KEY FINDINGS OF SPINE BIOLOGICS MARKET:

  • The demineralized bone matrix segment is expected to grow at a CAGR of 3.4%, owing to its ability to stimulate bone formation.
  • Synthetic bone grafts segment accounted for more than half of the global bone graft substitutes market in 2015.
  • North America contributed two-thirds share of the global spine biologics market in 2015.
  • France and Germany jointly accounted for more than one-third share of the European spine biologics market in 2015.
  • Japan is the major shareholder in the Asia-Pacific spine biologics market, accounting for more than one-third share in 2015.

North America is expected to maintain its dominance throughout the forecast period. However, Asia-Pacific region is projected to grow rapidly during the forecast period, registering a CAGR of 5.3%. Improving healthcare infrastructure and increase in expenditures in the emerging markets, such as India and China, to cater to the unmet medical needs in these countries have bolstered the market growth.

The key players in the spine biologics market are focused on expanding their business operations in the fast-growing economies with new product launches as the preferred strategy. The major companies profiled in the report include Alphatec Holdings, Inc., Depuy Synthes (Johnson & Johnson), Exactech, Inc., Globus Medical, Inc., Medtronic plc, NuVasive, Inc., Orthofix International N.V., RTI Surgical, Inc., SeaSpine, and Zimmer Biomet Holdings, Inc.

Read more about this research into the Medical Devices market: https://www.alliedmarketresearch.com/life-sciences/medical-devices-market-report

About Us:

Allied Market Research (AMR) is a full-service market research and business-consulting wing of Allied Analytics LLP based in Portland, Oregon. Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of “Market Research Reports” and “Business Intelligence Solutions”. AMR has a targeted view to provide business insights and consulting to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domain.

We are in professional corporate relations with various companies and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry.

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SOURCE Allied Market Research