IMPLANET: Update on the L&K BIOMED Partnership

Posted On January 31, 2018 By OrthoSpineNews In Spine /

January 30, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY) (Paris:ALIMP) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants has released a progress update on the partnership it entered into with South Korean company L&K BIOMED Co. Ltd in December 2017.

On December 6, IMPLANET announced it had entered into a preliminary agreement concerning the implementation of a worldwide partnership with L&K BIOMED in order to accelerate its expansion, especially in the United States and in Asia.

The distribution agreement with AEGIS SPINE, L&K BIOMED’s US subsidiary, has now been completed, in line with previous announcements. IMPLANET will capitalize on the expertise of Aegis Spine to complement the existing commercialization efforts in the United States, the company’s priority market.
The first surgeries with AEGIS SPINE’s KOLs are scheduled for early February.

In conjunction, both companies’ Asian and European teams are working on regulatory, marketing and commercial aspects of the two product line launches in their respective markets. L&K BIOMED’s technical and sales teams will undergo training at IMPLANET’s headquarters in early February. Cross-distribution agreements covering these geographical territories are due to be signed in the next few weeks.

Next financial press release: full-year 2017 results on Thursday, March 14, 2018

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2017 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward-looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

Paradigm Spine Announces Landmark Publication Of coflex® Vs. Decompression Alone In The Journal Of Neurosurgery Spine

Posted On January 29, 2018 By OrthoSpineNews In Spine, Top Stories /

NEW YORK, Jan. 29, 2018 /PRNewswire/ — Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced publication of the ESCADA 2-year trial results (European Study of coflex And Decompression Alone) in the January 2018 issue of the Journal of Neurosurgery Spine (JNS), official journal of the American Association of Neurological Surgeons (AANS). ESCADA reports a prospective, randomized, controlled, multi-center trial comparing decompression alone to decompression with coflex^® Interlaminar Stabilization^® for treatment of moderate to severe lumbar spinal stenosis. coflex is the first and only motion preserving minimally invasive treatment for moderate to severe spinal stenosis post decompression. A total of 225 patients were enrolled in the study with 91% follow up at 2 years.

The study authors concluded that decompression with coflex Interlaminar Stabilization extends the durability and sustainability of a decompression procedure.

“These data strongly validate for the surgical spine community that coflex is a safe and effective protector of a decompression procedure,” said Marc Viscogliosi, President and CEO of Paradigm Spine. “This means that surgeons treating patients with lumbar spinal stenosis can be more confident than ever in their treatment options, knowing that a randomized controlled trial has demonstrated with statistical significance that nearly twice as many patients with decompression alone have a risk of secondary intervention as compared to coflex patients. coflex is the first and only lumbar spinal device that has produced the highest level of evidence in two separate prospective, randomized, controlled studies against two different control groups – which exhibits the thoroughness and reproducibility of these findings. There is now potentially a more effective surgical option between the two typical treatments for lumbar spinal stenosis, and we are proud to lead the way in changing the standard of care for surgeons and their patients with this diagnosis.”

Highlights of ESCADA results:

The rate of patients achieving Composite Clinical Success was statistically superior in the coflex group vs. the Decompression Alone group (p=0.017)
Patients who received Decompression Alone experienced significantly more loss of foraminal and posterior disc height maintenance compared to the coflex group (p<0.001)
The Decompression Alone group experienced 228% more subsequent epidural steroid injections compared to the coflex group (p=0.0065)
coflex patients experienced 2.4 times more improvement in walking distance measurements compared to Decompression Alone patients (p=0.062)
At 24 months, the Decompression Alone group was 1.4 times more likely to be taking opioids compared to the coflex group

The ESCADA trial included seven sites in Europe / Germany with a total of 225 patients who were randomized to either decompression alone (DA, control group) or decompression with coflex Interlaminar Stabilization (coflex, study group). Overall trial success was based on a combined outcome measure called Composite Clinical Success (CCS), in which all four components must be met: 1) ODI success with improvement > 15 points; 2) survivorship with no secondary surgical interventions or lumbar injections; 3) neurologic maintenance or improvement without worsening; 4) no device-related severe adverse events. This is the same success criteria that was used in the U.S. IDE study of coflex that has published 5-year follow-up, allowing some direct comparisons to be drawn between the cohorts representing 547 patients collectively. Secondary measures were also collected such as walking distance, foraminal and disc height maintenance, leg and back pain scores, and opioid use.

“With the important work of the ESCADA trial, we can see that coflex extends the success and durability of a decompression procedure for lumbar spinal stenosis, while still allowing natural motion to occur,” says ESCADA author and Principal Investigator Professor Michael Rauschmann. “The U.S. IDE study first investigated and defined the long-term problems with lumbar fusion procedures that can be alleviated with coflex. And now, through this controlled trial, we can begin to answer the questions of the sustainability of decompression alone, and the need to provide additional stabilization for those patients with coflex at first surgical intervention to avoid future complications.”

Journal of Neurosurgery Spine. January 2018. Volume 28, Issue 1 (http://thejns.org/doi/full/10.3171/2017.11.SPINE17643).

About Lumbar Spinal Stenosis (LSS)
Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion. Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

About Paradigm Spine, LLC:
Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company’s signature product is the coflex^® Interlaminar Stabilization^® device, which is currently used in over 50 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

SOURCE Paradigm Spine, LLC

Inspired Spine Expands Global Access to Its Breakthrough Spinal Surgery

Posted On January 25, 2018 By OrthoSpineNews In Spine /

BURNSVILLE, MINN. (PRWEB) JANUARY 24, 2018

Inspired Spine today announced advancements in its strategy to evolve the global standard of care in spinal fusion surgery. Inspired Spine is creating a center for advanced minimally invasive spine surgery at the Canadian Specialty Hospital in Dubai, led by Dr. Mohammed Nooruldeen, and completed its first telemedicine consults with surgical patients there last week. As the first step in providing Inspired Spine’s advanced surgical solutions to their patients, surgeons in Seoul, South Korea participated in a live educational session to learn more about Inspired Spine’s innovative treatment approaches.

“We have established a true global presence for our cutting-edge advanced minimally invasive spine treatments and protocols,” said Dr. Hamid Abbasi, MD, FACS, FAANS, Chief Medical Officer. “Over the last two years, we have created the infrastructure and a rigorous training mechanism to enable other surgeons to learn our techniques. In addition, our protocols ensure that an Inspired Spine patient receives the same level of excellent care whether in the US, South Korea, Dubai, or anywhere else in the world.” Dr. Abbasi is the global leader in the Oblique Lateral Lumbar Interbody Fusion (OLLIF) technique, which is transforming the standard of care for treating many of the causes of chronic back pain, including: degenerative disc disease, herniated discs, spondylolisthesis, scoliosis, and spinal stenosis. For more information about the OLLIF procedure please visit: http://inspiredspine.com/minimally-invasive-ollif-faq/.

Inspired Spine recently opened a 120,000 square foot Total Spinal Health and Technology Campus in Burnsville, MN to scale its global training program, enabling more surgeons to learn its techniques. Six peer- reviewed studies have been published on the superior outcomes delivered by its surgical techniques versus the current standard of care, including a minimally invasive fusion approach for effectively treating adult degenerative scoliosis. Multiple surgeons throughout the world are in various stages of Inspired Spine’s “soft transition” training program.

About Inspired Spine
Minnesota-based Inspired Spine is a total spine care provider dedicated to improving treatment value and outcomes by applying the least invasive solutions to back-pain problems. Inspired Spine Centers offer a variety of treatment options for chronic back pain sufferers – from advanced diagnostic technologies, such as open, upright MRIs, to a range of conservative non-surgical therapies, in addition to unique minimally invasive outpatient keyhole surgical techniques. The company is building a network of comprehensive care centers that offer conservative care, such as physical therapy and pain management, as well as groundbreaking minimally invasive outpatient surgeries that reduce costs and speed recovery for patients. For more information, visit http://inspiredspine.com/ and follow Inspired Spine on Twitter @InspiredSpine.

Published Data Show Successful 24-Month Sacroiliac Joint Fusion and Pain Reduction with the SImmetry® System

Posted On January 25, 2018 By OrthoSpineNews In Spine, Top Stories /

January 24, 2018

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical, Inc. (Nasdaq: RTIX), a global surgical implant company, today announced the peer-reviewed publication of two-year data of the SImmetry Sacroiliac Joint Fusion System in The Open Orthopaedics Journal. The data show SImmetry provides radiographically evident sacroiliac (SI) joint fusion as early as 12 months with higher fusion rates observed at 24 months, while effectively reducing pain in patients with SI joint disorders. The SImmetry Sacroiliac Joint Fusion System is designed to treat SI joint dysfunction, an underserved condition and, according to the Centers for Disease Control and Prevention (CDC), one of the nation’s leading causes of lower back pain.

“This study demonstrated the SImmetry System effectively promoted SI joint fusion through decortication and also demonstrated a reduction in pain,” said Camille Farhat, President and CEO, RTI Surgical.

This multi-site study evaluated long-term fusion and pain reduction in 18 patients. The study examined computed tomography (CT) evidence of fusion at 12 and 24 months following SI joint fusion performed with decortication and bone grafting. CT scans were independently assessed by three trained musculoskeletal radiologists blinded to one another’s assessments. Fusion was predefined as Solid (presence of solid continuous bridging bone across the treated joint), Possible (presence of possible continuous bridging bone across the treated joint), or No Fusion (no bridging bone). At 24 months post-surgery, 17 of 18 patients (94 percent) had evidence of bridging bone, with 15 of 18 patients (83 percent) categorized as Solid fusion across the SI joint. Of the patients with bridging bone, 15 of 17 (88 percent) were fused within the area of decortication, demonstrating the importance of this step in achieving fusion.

In addition to fusion, the study demonstrated a 73 percent reduction in average pain at 24 months, maintaining the significant pain relief reported at earlier time points. No procedure- or device-related serious adverse events were reported. These data were presented at the International Society for the Advancement of Spine Surgery (ISASS) 2017 Annual Meeting.

RTI Surgical recently acquired the SImmetry Sacroiliac Joint Fusion System, a burgeoning therapy that accentuates RTI’s robust spine portfolio and accelerates the company’s growth.

“This is the first of many publications of clinical data demonstrating the value of SImmetry for patients with SI joint pathology,” Farhat said. “RTI is committed to furthering the body of clinical evidence supporting this technology.”

RTI continues to gather clinical data to support SImmetry, including the EVoluSIon Clinical Study, to include up to 40 sites and 250 patients evaluating SI joint fusion and pain reduction. More than 150 patients have been enrolled to date. An early analysis of the first 50 patients reported in December 2017 showed 72 percent of patients achieved the minimal clinically important difference of ≥ 20-point improvement in SI joint pain through six months. Further, the study showed a 54 percent reduction in mean SI joint pain at six months and, notably, the reduction in opioid use (55 percent) was much greater than previously reported with other SI joint fusion products.

The CDC lists back problems as the second most common cause of disability in U.S. adults¹. Approximately 20 percent of all chronic low back pain derives from the sacroiliac joint².

About RTI Surgical, Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements, gaining market share and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. Additionally, the statement relating to the expected size of the SIJF market in the United States in 2024 is a forward-looking statement. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

¹ Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.

² Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

Contacts

RTI Surgical, Inc.
MEDIA CONTACT:
Molly Poarch, +1-224-287-2661
mpoarch@rtix.com
or
INVESTOR CONTACT:
Nathan Elwell, +1-847-530-0249
nelwell@lincolnchurchilladvisors.com

Spine Wave Announces the Commercial Launch of the GraftMag® Graft Delivery System

Posted On January 23, 2018 By OrthoSpineNews In Spine /

SHELTON, Conn., Jan. 23, 2018 (GLOBE NEWSWIRE) — Spine Wave is pleased to announce its commercial launch of the GraftMag® Graft Delivery System. The GraftMag® Graft Delivery System is designed to safely and rapidly deliver large amounts of bone graft. The system can transform the tedious and sometimes frustrating graft delivery process into a more efficient part of thoracolumbar spinal fusion surgeries and, due to less instrument passes by sensitive patient anatomy, may reduce the risk of injury.

The GraftMag® Graft Delivery System is comprised of two single use, 5cc graft magazines that are loaded with bone graft on the back table. The magazines couple with the system’s specially-designed funnels to rapidly deliver large amounts of graft in 1cc increments. This new grafting approach can reduce frustrating funnel jams and requires only one instrument pass into the graft site to complete the grafting procedure. The GraftMag® Graft Delivery System can be used in virtually any thoracolumbar spine fusion procedure and with any interbody device. However, it fits particularly well with Spine Wave’s exciting line of expandable interbody fusion products, especially the Leva® Interbody Devices, which are well known for uniquely accommodating large amounts of bone graft with their use.

“Clinical research indicates that fusion rates are positively correlated with the amount of implanted graft material. I developed the GraftMag® Graft Delivery System with Spine Wave to make delivering large amounts of graft material faster, easier, safer, and less costly when used in conjunction with any interbody device,” said Dennis Crandall, M.D., Medical Director of Sonoran Spine in Tempe Arizona, and Chairman of the Sonoran Spine Research and Education Foundation. “Using the GraftMag® Graft Delivery System in conjunction with Spine Wave’s line of Leva® Interbody Devices is a particularly compelling option for many of my thoracolumbar spinal fusion procedures because those devices can accommodate so much graft.”

About Spine Wave
Spine Wave is a leader in expandable fusion technologies and is committed to continually delivering highly differentiated products to enable more efficient and less invasive solutions for spine surgeons and their patients. In addition to the GraftMag® Graft Delivery System, Spine Wave also offers a broad portfolio of expandable devices marketed under the StaXx®, Velocity® and Leva® brand names. The expandable technologies can be utilized in posterior, anterior and lateral surgical approaches. To complement the expandable spacers, Spine Wave offers a comprehensive line of pedicle screws for both minimally invasive and traditional open approaches. Additionally, Spine Wave recently launched the Proficient® Posterior Cervical Spine System which is being very well received due to the high degree of angulation offered by its unique screw design. The company is expanding rapidly and continues to recruit sales managers and independent distributors to fuel growth. For more information on Spine Wave and its products, please visit www.spinewave.com.

Contact
Terry Brennan, Chief Financial Officer
tbrennan@spinewave.com
(203) 712-1810

IMPLANET: Successful First Surgical Procedures with the Jazz Lock® in Brazil

Posted On January 18, 2018 By OrthoSpineNews In Spine /

January 17, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today is announcing the successful results of the first surgeries using JAZZ Lock® in Brazil.

The first JAZZ Lock® procedures follow ANVISA clearance in November 2017. The initial surgeries in Latin America confirm Implanet’s global strategy to carry out the international launch of JAZZ Lock® initiated in 2017.

JAZZ Lock® fixation is the first component of an innovative range of band products designed for degenerative spine disorder surgery. JAZZ Lock® broadens the JAZZ technological platform, allowing Implanet to expand its reach in a spine market estimated to be worth over $200 million worldwide¹ and $3.1 million in Brazil. Implanet offers surgeons a new implant with an optimized and reproducible surgical technique. Based on the polyester band platform, JAZZ Lock® simplifies the surgical procedure by replacing the locking screw and connecting rod with an innovative locking system.

Dr. Alexandre Elias, member of the Pain and Functional Neurosurgery Department at Hospital 9 de Julho in São Paulo and former Chief of the Spine Department at University UNIFESP says: “As a Neuro surgeon, I have been using Implanet’s band implants, with excellent post-operative clinical results. The arrival of JAZZ Lock® as part of the Implanet band range in Brazil is a major breakthrough. This new implant, easy to use during the first surgery in Sao Paulo, as well as the highly encouraging initial post-operative clinical results, validates our choice. We will now follow these patients to confirm the long term results. In my opinion, JAZZ Lock® will quickly become an essential spine implant to surgeons.”

Alvaro Tadeu dos Santos Jr, CEO of Importek says: “Completing with Implanet the ANVISA registration of the JAZZ Technology platform by end 2017 was our major goal. JAZZ Lock® is now part of the enhanced JAZZ Range, now available in Brazil. This will drive the deployment of the technology platform in our domestic market via our direct sales force organization.”

Ludovic Lastennet, CEO of Implanet, adds: “As announced we are executing our commercial deployment plan. Following the regulatory clearance in Europe (CE) and the US (FDA), JAZZ Lock® is now cleared for use in Brazil (ANVISA). The positive results obtained in the first surgeries in multiple regions of the world illustrate this product’s potential for patients and surgeons alike.”

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80¹ Source: i-Data for 2010

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot
Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

SPINEWAY : 1st complex surgery performed in the USA with Spineway’s MIS implants

Posted On January 16, 2018 By OrthoSpineNews In Spine /

Ecully, 15 January 2018

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces that the Texas Back Institute (TBI), a group of US hospitals specializing in neck and back pain, performed the first operation addressing scoliosis via minimally invasive surgery using the Group’s MONT-BLANC MIS implants.

This complex operation was successfully performed by Dr. Theodore Belanger at the Texas Health Presbyterian Hospital and positions Spineway as an innovative player in the treatment of scoliosis. Indeed, very few laboratories in the world offer solutions adapted to deforming conditions such as scoliosis with a minimally invasive approach.

Prior to this implant, Texas Back Institute performed a series of fifteen surgeries with Spineway’s MONT-BLANC MIS implants de Spineway on patients with degenerative conditions.

With 40 years’ experience, TBI is currently one of the biggest top-level multidisciplinary university centers in the US. With 9 medical centers and over 20 surgeons throughout the state of Texas, TBI is well-known and has cutting-edge expertise in the treatment of back conditions.

Theodore Belanger, Orthopedic Spine and Scoliosis Surgeon at TBI, said the following about this partnership: “I feel there is great promise in the innovative thinking at the core of Spineway, and I look forward to a strong working relationship between the company and the Texas Back Institute over the coming years!”

Building on this major step forward, Spineway will continue its expansion in the United States and confirms a sharp increase in its revenue for the 2017 financial year.

This press release is available in both English and French. In case of discrepancy, the French version shall prevail.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME

Find out all about Spineway at www.spineway.com

Next communication:
2017 annual revenue – 17 January 2018, 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 – Euronext Growth

Contacts:


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

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/8ad5a411-2b11-4b70-882a-c93aa16f26e9

EIT Emerging Implant Technology announces first FDA multilevel approval for their 3D printed cervical cage

Posted On January 16, 2018 By OrthoSpineNews In Regulatory, Spine, Top Stories /

TUTTLINGEN, GERMANY (PRWEB) JANUARY 16, 2018

Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative 3D printed titanium implants for spinal applications today announced the U.S. Food and Drug Administration (FDA) clearance of the expansion of the label of their EIT Cellular Titanium® Cervical Cage to be used in multiple contiguous cervical levels (C2 to T1).

EIT Cellular Titanium® is a 3D printed porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize cell proliferation and bone ingrowth. The anatomical design of the EIT cervical cage assists the surgical and biomechanical challenges of cervical multi-level fusion by adapted to maximized vertebral endplate contact and sagittal balance restoration.

The fusion potential of the implants is supported by EIT’s proprietary 3D process including post-printing etching procedures, allowing for unique porous structures that are impossible to manufacture with traditional manufacturing techniques. “This is another important regulatory milestone for EIT,” said Guntmar Eisen, Founder and CEO of EIT. “Only very few cervical cages are approved for multilevel use and we are poised to quickly enter the US market with the most advanced technology and state of the art FDA labeling and compliance.”

This marks the first multi-level 3D printed cervical cage to enter the US market. The EIT cervical cage is to be used with supplemental fixation and designed for use with autogenous and/or allogenic bone graft to facilitate fusion. Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), assisted EIT on the FDA strategy and submission. Justin Eggleton, Senior Director of Regulatory Affairs commented “this clearance represents continued synergy between FDA and the medical community. The expanded indications to multiple levels in the cervical spine facilitates improved surgeon collaboration and the ability to collect data that will strengthen the total product lifecycle, which ultimately benefits patients.”

The company’s plans to complete the current product portfolio with a lateral lumbar cage in Q2 and a fully printed lateral expanding cage in Q4. For more information about the EIT 3D platform, visit http://www.eit-spine.de

About EIT

EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.

The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.

A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 15.000 EIT cases have been performed in over 15 markets globally. EIT has started to launch its products in the US in Q4 of 2017.

Life Spine Achieves Monumental Sales Growth of ProLift® Expandable Spacer System for 2017

Posted On January 16, 2018 By OrthoSpineNews In Spine, Top Stories /

January 16, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that revenues for ProLift Expandable Spacer System grew by 493% for 2017 as compared to 2016. “With the introduction of ProLift to the market in 2016, we have consistently experienced monumental sales growth quarter over quarter,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine. “We are excited about the adoption of ProLift, and will continue to focus on technological advancements that strive to improve surgical efficiencies and patient outcomes through our Micro-Invasive Expandable Solutions. Products such as ProLift, TiBOW™, and LONGBOW^® are the core competencies which we will continue to drive for our procedurally based product portfolios”.

Life Spine’s continued focus on Micro-Invasive Technologies includes additional clinical and procedural solutions with the AVATAR^® Percutaneous Screw System, AILERON^® Interspinous System, SIMPACT^™ and TRI-FIN SI Joint Fixation, and the CENTRIC^® family of retractors.

Zeshan Hyder, D.O., of Bone and Joint Specialists of Northwest Indiana notes, “The continued evolution of MIS surgery to reduce tissue morbidity, and restore anatomical alignment, especially in severe degenerative and collapsed disc, is being achieved in my practice with the expandable technologies such as ProLift, and the lateral system LONGBOW. Both of these systems reduce the requirements for multiple instrument passes by important neural structures while maintaining my surgical goals and positive patient outcomes. Additionally, ProLift provides me the benefits of reduced graft subsidence, seen in other titanium implants. This has been a game changer for my practice.”

ProLift continues Life Spine’s commitment of offering innovative Micro-Invasive procedural solutions to better improve patients’ lives. In addition, Life Spine launched its new website highlighting their complete core and Micro-Invasive procedural solutions. The website is a staple to the new look of Life Spine, and helps surgeons access information about advancements in surgical innovations.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

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Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Intellirod Spine’s New High-tech Measurement of Spine Healing

Posted On January 15, 2018 By OrthoSpineNews In Spine /

Posted 1/12/2018 by Dann Bruno

These days, wireless technology is increasingly becoming part of the nuts and bolts of innovative design.

From automobiles to oil wells, devices and machines are transmitting data wirelessly—information that measures performance, provides failure alerts, and helps the human users have a better experience.

Now, Intellirod Spine adds to the list with implantable, wireless, monitoring systems designed to measure the progress of spine healing after lumbar surgery.

From inside the body, these sensors send physicians the data they need to achieve potentially better patient outcomes, both during surgery and post-operatively.

Better Data Contributes to Better Outcomes

Each year in the U.S., more than 450,000 lumbar spinal fusions are performed to treat fractures and instability, to correct deformities, or to eliminate pain. In these procedures, the surgeon positions bone grafts around the spine; the goal is for the body to grow new bone to connect (or fuse) the grafts to existing vertebrae.

During surgery, a system of metal rods and screws, typically made of titanium or cobalt chrome, is implanted to stabilize the spine and help it heal.

“Strain on the implanted rods lessens as new bone grows after surgery,” said Ric Navarro, president and CEO of Intellirod Spine. “When the spine doesn’t fuse, there is more strain on the rods.”

Currently, surgeons use radiography and CT scans during recovery and rehab to determine whether the spine is successfully fusing and growing new bone after surgery. Intellirod Spine’s wireless sensors provide mechanical data on the strain on the rods. This information compliments medical assessments from x-ray or CT scans.

“We are undergoing clinical studies to collect data for FDA at the Cleveland Clinic, the OhioHealth Grant Medical Center, and the Norton Leatherman Spine Center in Louisville and seeking a fourth site, said Navarro, who has more than 25 years of medical device and implant experience in artificial heart, operating room equipment, and spinal implants. He has also been inventor on 22 patents and has commercialized numerous spine and operating room products.

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Better Data Contributes to Better Outcomes