NuVasive To Present At The 36th Annual J.P. Morgan Healthcare Conference

Posted On January 3, 2018 By OrthoSpineNews In Spine /

SAN DIEGO, Jan. 3, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today that management will present at the 36th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis in San Francisco on Monday, Jan. 8, 2018, at 1:30 p.m. PT / 4:30 p.m. ET.

A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentation will remain available on the website for 30 days after the applicable live webcast.

About NuVasive

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

Forward-Looking Statements

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

SOURCE NuVasive, Inc.

First ever Haven Lamina Replacement performed by Dr. Graham Mouw of Robotics Outpatient Center, Los Angeles, CA: ROC – LA

Posted On January 3, 2018 By OrthoSpineNews In Spine /

LOS ANGELES, Jan. 3, 2018 /PRNewswire/ — Robotics Outpatient Center, Los Angeles, CA, “ROC-LA” announces today the First Surgical Implantation of the Globus “Haven” Lamina Replacement Implant, in California by Spinal Neurosurgeon Graham Mouw, MD.

This surgery is part of Robotics Outpatient Center’s efforts to expand the use of the Globus “Haven” Lamina Replacement System worldwide.

The surgery was performed at Valley Presbyterian Hospital by the surgeon team of Dr. Graham Mouw.

The HAVEN™ Laminoplasty System is a dual plate system that uniquely offers bilateral lamina support, bridging the posterior arch to help protect the spinal cord.
Bilateral Advantage
Bilateral fixation to the lateral masses provides a rigid supporting structure to bridge the posterior arch with one continuous implant.
Natural Anatomic Design
Implant design mimics intact anatomy.
Non-Fusion Plate Configurations

The Haven System is a very intuitive and easy to use system that allows the performance of short and safe surgery while avoiding the risk of nerve injury and maintain Full Motion of the Spine,” said Dr. Graham Mouw: “As a Developer of the Implant, the entire system is very intuitive, simple and delivered via a micro-incision,” stated Mouw.

Dr. Mouw is very excited to perform his surgeries at the Robotics Outpatient Center, at Los Angeles: ROC-LA.

Located at 1127 Wilshire Blvd, Suite 1000 Tenth Floor, Los Angeles, CA 90017.

“Dr. Mouw is Inventor and Developer of the Motion Spine Institute where “Motion Preservation” is changing spine surgery,” said Derek Dee, MD, President of Robotics Outpatient Center, Los Angeles, ROC-LA.

www.roboticsoutpatientcenter.com; 213-328-3600.

www.rockthepain.com

info@palengensurgery.com
info@rockthepain.com

SOURCE Robotics Outpatient Center

Multi-center Study on SImmetry Sacroiliac (SI) Joint Fusion Shows Significant Reduction in Low Back Pain and Opioid Use at 6 Months

Posted On January 2, 2018 By OrthoSpineNews In Spine, Top Stories /

MINNETONKA, Minn., Jan. 2, 2018 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced publication of clinical outcomes for the first 50 patients in the EVoluSIon (EVSI) Clinical Study. This prospective, 40-site, 250-patient trial will evaluate long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

At 6 months, mean low back pain as measured on a 100-point Visual Analog Scale (VAS) demonstrated a significant reduction from 76.2 pre-operatively to 35.1 (54% reduction, p<0.0001), with 72% of patients attaining the minimal clinically important difference (MCID, ≥20 point improvement). While pain and disability improvement is comparable to similar studies, the reduction in opioid use (55%) was much greater than previously reported in other studies. Additional follow-up will be performed at 12- and 24-months to assess the presence of bony fusion across the joint via CT imaging as well as ongoing pain reduction.

“It is very exciting to see prospective, multi-center clinical data reaffirm the positive feedback I’ve received from my patients over the past few years,” said Ali Araghi, D.O., an orthopedic surgeon at Core Institute in Phoenix, Ariz. and lead author of the publication. “As a physician working with patients who are in significant pain, it is also incredibly meaningful to know I have a surgical option that can reduce the need for opioid medications. Longer-term follow-up and CT imaging will be important to demonstrate the longevity of these results, but this is very encouraging for our first look at the data.”

Earlier this year, the Company released results of a 19-patient, prospective, multi-center study of Minimally Invasive Sacroiliac Joint Fusion Surgery with Decortication. At 24 months post-op, 94 percent of patients had evidence of bridging bone across the SI joint, with 83 percent categorized as solid fusion. Of patients with solid fusion, 88 percent of the joints 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. The EVSI study is designed to build on the findings of this study.

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adults^[i]. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac joint^[ii].

About Zyga Technology, Inc.

The company is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The SImmetry System is known for its ability to create a true SI joint arthrodesis, including decortication, bone grafting and fixation with a threaded implant. For more information, visit zyga.com.

[i] Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
[ii] Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Maggie Wallner
Tel 952 698 9953
mwallner@zyga.com

SOURCE Zyga Technology, Inc.

ApiFix Ltd. Announces New Leadership

Posted On January 2, 2018 By OrthoSpineNews In Spine /

Misgav, Israel – 2 January 2018 –ApiFix Ltd. (“ApiFix”), a portfolio company of The Trendlines Group Ltd. (“Trendlines”) (SGX: 42T; OTCQX: TRNLY),announced the appointment of Ed Roschak as Chairman of the Board of ApiFix and Paul Mraz as President and CEO of ApiFix. ApiFix provides minimally invasive non-fusion solutions for the treatment of spinal scoliosis.

Mr. Roschak served as President and Chief Executive Officer of Ellipse Technologies, Inc. from 2011 until 2016, when it was acquired by NuVasive, Inc. for US$410 million. Ellipse Technologies developed a magnetic growth rod technology for treating early onset scoliosis of the spine and for limb lengthening procedures.

Mr. Mraz brings 25+ years of spine and orthopedic medical device experience to ApiFix, having worked as CEO and in other senior positions in U.S.- and Israel-based companies. Mr. Mraz’s experience includes executive management (14 years as CEO), corporate strategy, product development and marketing, sales management, and business development – all on a global basis. Previously, Mr. Mraz served as managing partner of business strategy and leadership consulting firm OnPoint Advisors, which he founded in 2013. From 2006 to 2013, Mr. Mraz served as president and CEO of medical device and biologics company Cerapedics, Inc., which developed and is now commercializing biologic bone grafting products for the spine and orthopedic markets.

Todd Dollinger, CEO and Chairman of Trendlines and outgoing ApiFix chairman, commented, “We believe the deep experiences Ed and Paul bring make them ideal to take ApiFix to the next level and we are excited to welcome them on board. Trendlines is extremely proud of ApiFix’s achievements to date and we’re confident that the combined efforts of Ed and Paul will be instrumental in realizing ApiFix’s strategic focus on the U.S. and European markets as ApiFix finalizes its application for FDA clearance.” Dollinger cited Roschak’s substantial work in every aspect of building a scoliosis treatment company as key reasons ApiFix sought to bring him in as Chairman of the ApiFix Board. Similarly, Mraz has extensive leadership experience bringing innovative spine technologies to market for the benefit of patients and all stakeholders. With ApiFix’s U.S. market entry plans in process, Mraz will establish ApiFix’s U.S. headquarters in the Boston, Massachusetts USA area. R&D and manufacturing activities will remain in Israel under the leadership of ApiFix’s co-founder and CTO, Uri Arnin.

The ApiFix system is a disruptive platform technology with its less invasive, non-fusion scoliosis correction system implanted in a short procedure that maintains spine flexibility and requires only a brief recovery period. The ApiFix system has CE Mark certification and is available in Europe and Canada.

The ApiFix Board of Directors expresses its deep gratitude to Eran Feldhay, M.D., for his contributions as CEO. Dr. Feldhay’s leadership brought ApiFix through critical commercialization milestones positioning it well for this next evolution.

About The Trendlines Group Ltd.

Trendlines is an innovation commercialization company that invents, discovers, invests in, and incubates innovation-based medical and agricultural technologies to fulfill its mission to improve the human condition. As intensely hands-on investors, Trendlines is involved in all aspects of its portfolio companies from technology development to business building.Trendlines’ shares are traded on the Singapore Stock Exchange (SGX: 42T) and in the United States as an American Depositary Receipt (ADR) on the OTCQX (OTCQX: TRNLY).

About ApiFix Ltd.

ApiFix is a privately held, innovation-driven, medical device company developing a non-fusion platform technology for the less invasive surgical correction of adolescent idiopathic scoliosis (AIS) and early onset scoliosis (EOS). ApiFix is led by a team of highly-regarded spine surgeons and spine industry veterans.

*******

This press release has been prepared by The Trendlines Group Ltd. (the “Company”) and its contents have been reviewed by PrimePartners Corporate Finance Pte. Ltd. (the “Sponsor”) for compliance with the Singapore Exchange Securities Trading Limited (the “SGX-ST”) Listing Manual Section B: Rules of Catalist. The Sponsor has not verified the contents of this press release.

This press release has not been examined or approved by the SGX-ST. The Sponsor and the SGX-ST assume no responsibility for the contents of this press release, including the accuracy, completeness or correctness of any of the information, statements or opinions made or reports contained in this press release.

The contact person for the Sponsor is Ms. Gillian Goh, Director, Head of Continuing Sponsorship (Mailing Address: 16 Collyer Quay, #10-00 Income at Raffles, Singapore 049318 and E-mail:sponsorship@ppcf.com.sg)

Investor Contact Information: Israel

Judith Kleinman, Director Investor Relations & Corporate Communications The Trendlines Group judith@trendlines.com Tel: +972.72.260.7000

Singapore:

Reyna MEI Financial PR reyna@financialpr.com.sg Tel: +65.6438.2990

SI-BONE, Inc. Announces BCBS Association Raises Clinical Evidence Rating for MIS SI Joint Fusion

Posted On January 2, 2018 By OrthoSpineNews In Spine, Top Stories /

SAN JOSE, Calif., Jan. 2, 2018 /PRNewswire/ — SI-BONE, Inc., a medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Blue Cross Blue Shield Association (BCBSA), after an extensive review of all existing peer-reviewed published clinical safety and effectiveness data, has assigned triangular implants for SI joint fusion a “Moderate” quality evidence recommendation. The BCBSA rating system encompasses a four-level rating scale of Substantial, Moderate, Low to None and Uncertain. In order for a technology to receive a moderate or substantial rating, the clinical evidence must be sufficient to determine the effects of the technology on health outcomes with confidence. The BCBSA updated technology assessment states that for individuals with common disorders affecting the sacroiliac joint who are treated with sacroiliac fusion/fixation with a triangular implant, the evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome. The evidence used to develop the upgraded assessment was developed exclusively using the patented triangular iFuse Implants, which have been commercially available since 2009. The updated assessment further states that for patients with SI joint pain, the evidence is insufficient for treatment with therapeutic corticosteroid injections, radiofrequency ablation or cylindrical threaded implants.

The evidence required to establish a sufficient effect on health outcomes typically includes:

Consistent results from well-designed, well-conducted studies in clearly-defined populations.
Well designed and conducted studies generally controlled for bias through random allocation of participants; blinded assessment of outcomes; minimizing loss to follow-up; and complete reporting of results. Study populations are representative of the population of clinical interest. Study size is adequate to test the hypothesis and assumptions for calculating study power are clearly reported.
Studies assessing the effects of the technology on health outcomes, including both the beneficial and harmful effects on length of life, quality of life and ability to function.
Evidence from effectiveness studies or post-marketing studies that confirm that the observed effects of the intervention are generalizable outside the research setting.
Evidence from effectiveness studies or post-marketing studies to assess long term effects of the technology on health outcomes.

Clinical study data available through a curated open data access source.
The Blue Cross and Blue Shield Association is a national federation of 36 independent, community-based and locally-operated Blue Cross and Blue Shield companies that collectively provide healthcare coverage for more than 106 million members across all 50 states, the District of Columbia and Puerto Rico.

Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE commented, “there is abundant evidence showing that the sacroiliac joint is a significant contributor to lower back pain and that common types of SI joint dysfunction can be effectively treated with a minimally invasive surgical procedure using the triangular iFuse Implant, which we brought to market in 2009. That said, the SI joint has been under-diagnosed and under-treated for decades and our philosophy has been to take a high level scientific approach, including well-designed and well-executed clinical studies so that the data from these studies could stand on their own for educational, clinical and patient purposes.”

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain 1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 SI joint dysfunction is often misdiagnosed and the resulting pain can be incorrectly attributed to other causes. SI joint dysfunction can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS), known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections to confirm the diagnosis. The SI joint is the largest of the eight major joints in the human body and the last to have a proven surgical treatment. The iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief. The iFuse Implant was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials (www.si-bone.com/results).

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain. Patients with certain types of sacroiliac joint dysfunction experience pain that can be debilitating.

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

1. Bernard TN, Kirkaldy-Willis WH. Recognizing Specific Characteristics of Nonspecific Low Back Pain. Clin Orthop Relat Res. 1987;217:266–80.
2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

SOURCE SI-BONE, Inc.

Hartford HealthCare Pioneers Robotic-Assisted Spine Surgery

Posted On December 22, 2017 By OrthoSpineNews In Robotics, Spine, Top Stories /

HARTFORD, Conn., Dec. 22, 2017 /PRNewswire/ — Hartford HealthCare (HHC) has pioneered a new, advanced technology at The Hospital of Central Connecticut, which is the first hospital in all of New England to use the new Globus ExcelsiusGPS™, a sophisticated surgical guidance system for spine procedures. The new technology also will soon be available at Backus Hospital.

The ExcelsiusGPS™ brings an even greater level of precision to surgeons performing spine surgery and the patients they serve. The ExcelsiusGPS™ system is the first robotic assisted navigation system that is used by surgeons during the procedure, in real time. It is designed specifically to make surgery safer, and help surgeons ensure implants and hardware placement is even more precise. The technology also enables minimally invasive spine procedures which are often linked to less blood loss, less muscle damage, and a faster recovery.

“We are innovators at Hartford HealthCare, and we have a long history of bringing the latest and most valuable technology to the patients and communities we serve,” said Jeffrey Flaks, Hartford HealthCare President and Chief Operating Officer. “We believe technology is a true partner in care — enabling our talented experts to improve outcomes, enhance quality and deliver an exceptional experience for our patients. This is a fitting next step as we continue to pioneer guidance technology in healthcare.”

Hartford HealthCare is a leader in robotic-assisted surgery, with an extensive surgical robotics program, which is aimed at improving patient outcomes and improving the quality of care. Hartford HealthCare has been using the da Vinci® Surgical System for several years, combining the latest in minimally invasive surgical and robotics technologies to perform successful complex as well as routine surgeries. In March, Hartford HealthCare became the first healthcare system in the state of Connecticut and throughout the Northeast to debut Mazor X robotic-assisted surgical guidance system.

About Hartford HealthCare. Hartford HealthCare is Connecticut’s most comprehensive health care network. Our fully integrated health system includes a tertiary-care teaching hospital, an acute-care community teaching hospital, an acute-care hospital and trauma center, two community hospitals, the state’s most extensive behavioral health services network, a large primary care physician practice group, a regional home care system, an array of senior care services, a coordinated cancer institute with five cancer centers, and a large physical therapy rehabilitation network. Visit us at www.hartfordhealthcare.org.

SOURCE Hartford HealthCare

Centinel Spine Completes Acquisition of Prodisc Assets

Posted On December 22, 2017 By OrthoSpineNews In Spine, Top Stories /

NEW YORK, Dec. 22, 2017 /PRNewswire/ — Centinel Spine, LLC (CS) is pleased to announce the acquisition of the worldwide assets of the prodisc® Total Disc Replacement portfolio from DePuy Synthes Products, Inc. The prodisc line of products are total disc replacement (TDR) products with the longest history of use globally. The prodisc® portfolio includes prodisc® C and prodisc® L in the United States and prodisc® VIVO, prodisc® NOVA, prodisc® C, prodisc® L, and prodisc® O, along with DISCOVER™ Cervical outside the United States.

This acquisition complements Centinel Spine’s existing spinal implant portfolio of leading technologies for anterior column support of the spine from cervical to lumbar. This includes the company’s standalone portfolio of STALIF C®, STALIF C-Ti™, MIDLINE II™, MIDLINE II-Ti™, and STALIF L™, as well as additional products ACTILIF™ Cervical Cage TRANSOM™ Plate, and ALTOS® PCT.

Centinel Spine, the pioneer of the No-Profile®, Integrated Interbody™ has a 30 year history of developing integrated interbody devices into a standard treatment for patients with degenerated disc disease. Centinel Spine will utilize the same clinical, regulatory, and development expertise to broaden acceptance and to increase carrier coverage and surgeon adoption of total discs worldwide.

“This transaction is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading company addressing spinal disease through anterior access to the spine with the widest breadth and depth of technology platforms,” said John J. Viscogliosi, Centinel Spine Chairman & CEO.

For background in understanding the acquisition, Viscogliosi Brothers, LLC, a lead investor in Centinel Spine, was the founder of Spine Solutions, Inc., the company that led the original IDE study to bring prodisc to the United States.

The company also completed debt and equity financing to close on the transaction and provide working capital. Piper Jaffray & Co. served as the sole placement agent for Centinel Spine.

About Centinel Spine, LLC.

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No- Profile, Integrated Interbody fusion technologies. For more information on Centinel Spine products and technologies, please visit the Company’s web site at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column support spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” – the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi	Wendy F. DiCicco
SVP, Corporate Finance & Strategic Planning	Chief Operating and Chief Financial Officer
Centinel Spine, LLC	Centinel Spine, LLC
900 Airport Road, Suite 3B	900 Airport Road, Suite 3B
West Chester, PA 19380	West Chester, PA 19380
Phone: 484-887-8871	Phone: 484-887-8837
Email: v.gandhi@centinelspine.com	Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, Inc.

Medical device maker says savings from new tax law to fuel innovation and growth

Posted On December 21, 2017 By OrthoSpineNews In Regulatory, Spine /

By DBJ Staff/Dec 21, 2017

Medical device maker NuVasive Inc. says savings from President Donald Trump‘s new tax reform will help it to fuel innovation and growth in its business, which could be a boon to local operations that are already experiencing growth.

San Diego-based NuVasive (NASDAQ: NUVA) announced today the potential implications to its business based on the recent passage by Republicans in the U.S. Congress and soon-to-occur signing by President Trump of the tax bill. The new bill will reduce the U.S. corporate tax rate from 35 percent to approximately 21 percent. This is the largest tax overhaul in 30 years and will significantly reduce the future corporate tax rate for NuVasive, which prior to the enactment of the tax overhaul was expected to be approximately 33 percent on a non-GAAP basis in 2018, the company said.

While the Company will be undertaking a thorough analysis over the coming weeks, early analysis indicates that the NuVasive non-GAAP tax rate will drop into the low 20 percent range in 2018 and in future periods converge to a 20 percent non-GAAP tax rate.

“The savings from this landmark decision are expected to boost forward-looking free cash flow and non-GAAP EPS well in excess of 10 percent per year beginning in 2018, delivering incredible incremental value-generating opportunities for our shareholders,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “Innovation requires fuel, and this surplus can support increased investments in R&D to provide solutions that empower spine surgeons to change the lives of their patients. This is a tremendous opportunity for the medical device industry, and a major spark in our ability to continue to invest in life-changing innovations.”

READ THE REST HERE

FH Orthopedics announces more than 6,000 spinal disc prostheses sold

Posted On December 21, 2017 By OrthoSpineNews In Spine /

(PR NewsChannel) / December 20, 2017 / HEIMSBRUNN, France

FH Orthopedics is proud to announce that sales of its Cervical Prosthesis (CP-ESP®) and Lumbar Prosthesis (LP-ESP®) has exceeded 6,000 units. Designed to replace damaged discs in the cervical (neck) or lumbar (lower back) regions of the spine, CP-ESP and LP-ESP prostheses mimics the function and range of movement of a natural disc and allows the spine to behave naturally.

Widespread interest in both of the ESP disc prosthesis, and their swift acceptance by orthopedic and neuro surgeons and their patients, highlights the strong desire for products that can restore quality of health and life. “Most patients for disc replacement surgery are up to forty or fifty years old and wish to maintain their mobility,” says Dr. Biren Desai, a specialist in orthopedic general and trauma surgery. “This type of surgery has been standardized now for many years and is performed quite routinely.”

ESP discs combine two titanium end plates with an elastomeric cushion made of polycarbonate urethane. This structure imitates the natural disc, in which bony segments are connected by a spongy disc that provides flexibility while withstanding the pressures of compression and torsion. Specific features of the end plates — short spikes, a rough outer surface, and a coating of hydroxyapatite (HA), which is proven to enhance bone ingrowth — help to ensure stability and bony fixation of the implant over time.

This design provides a number of benefits for orthopedic surgeons and their patients:

Adaptive center of rotation
Shock absorbing
Improved stability
No surface bearing for increased lifetime
Designed to fit and restore patient lordosis (spinal curvature)
Range of sizes to fit different patients
Minimally invasive surgical technique and shorter hospital stay

The CP-ESP prosthesis — indicated for use in cases of symptomatic cervical discopathy that have not responded to other medical treatments for at least six months — offers 7 degrees of flexion/extension, 5 degrees of lateral flexion, and 4.5 degrees of axial rotation.

The LP-ESP prosthesis — indicated for use in cases of lumbar disc disease, typically related to disc herniation, that have not responded satisfactorily to other treatments — offers 6 degrees of flexion/extension, lateral flexion, and axial rotation.

The quality and efficacy of ESP spinal implants, which has been demonstrated through years of clinical results, is frequently echoed in the sentiments of physicians who have used these implants with their own patients.

“The LP-ESP prosthesis has the advantage, compared to other prostheses, that it is similar to a natural disc,” says Andreas Schmitz, a specialist in neurosurgery. “The prosthesis mimics the natural disc. It absorbs the pressure from above and maintains mobility. It is made of two titanium plates covered with titanium porous coating which improves bone ingrowth. After three weeks, the prosthesis is tightly fixed to the spine.”

Schmitz goes on to say, “The LP-ESP prosthetic discs made by FH Orthopedics allow patients to rapidly return to work and to their daily activities.”

———————————————

For more than 50 years, FH Orthopedics S.A.S. has demonstrated passionate dedication to creating innovative implants, evaluating them, and following them clinically. The company promotes original products and techniques designed in collaboration with expert surgeons, distributes products worldwide from its ISO 9001/13485-certified distribution site, and provides unparalleled service that guarantees the confidence and loyalty of healthcare facilities.

FH Orthopedics is part of GROUP FH ORTHO, which designs, manufactures, and distributes high-quality orthopedic implants and instruments in France and further afield. Operating two companies in France and three subsidiaries in the UK, US, and Poland, GROUP FH ORTHO and its partners work together to offer services and products that guarantee the health and safety of its end customer: the patient.

———————————————

For more information, contact:

Eric Hermann
Spine Business Unit Director
FH Orthopedics
e.hermann@fhorthopedics.com
+33 6 14 28 82 30
contact@esp-disc.com

Direct link: https://www.prnewschannel.com/2017/12/20/fh-orthopedics-announces-more-than-6000-spinal-disc-prostheses-sold/SOURCE: FH Orthopedics S.A.S.

This press release is distributed by PR NewsChannel. Your News. Everywhere.

Fuse Medical, Inc. Signs Definitive Purchase Agreement to Acquire CPM Medical Consultants, LLC

Posted On December 21, 2017 By OrthoSpineNews In Biologics, Extremities, Recon, Spine /

December 19, 2017

RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc., (OTC: FZMD), (“Fuse” or the “Company”), announced today that it signed a definitive purchase agreement to acquire CPM Medical Consultants, LLC (“CPM”), a privately-owned nationwide distributor of medical device implants and biologics.

CPM is a stocking distributor with an extensive portfolio of orthopedic implants for total joint reconstruction, sports medicine, internal and external fixation products for extremities, and full spinal implants and instrumentation. CPM also offers an extensive assortment of biologics, which include human allograft with cell based products, regenerative tissue, and amniotic fluids to augment all types of surgical procedures.

Fuse expects the transaction to be accretive to 2018, and it anticipates the 2018 consolidated company revenues generated from its product sales and distribution to be at approximately $35 million. The transaction is subject to customary conditions of closing, which is expected to occur by December 31, 2017. Following the transaction, CPM will be a wholly-owned subsidiary of Fuse.

Management Commentary on Acquisition

Christopher C. Reeg, Chief Executive Officer of Fuse, said, “We are thrilled to have the CPM family join the Fuse team, and look forward to welcoming new business associates to Fuse. We are confident that the consolidated Fuse and CPM organizations will provide the necessary platform to achieve our numerous growth and expansion goals.”

“The acquisition of CPM is an ideal complement to our strategic objectives as it brings an experienced and proven distribution organization consisting of direct sales employees, independent sales agents, and sub-distributors who are focused in specific surgical areas. In developing our strategies in this market sector, we believe this new sales channel will provide us with an opportune pipeline for the expansion of national distribution and the launch of new product offerings, both internally developed and acquired,” added Mr. Reeg.

Mark W. Brooks, CPM Founder and Owner, stated, “We are excited with the expected benefits both organizations will gain from this transaction. CPM brings the ideal combination of broad product assortment, sales and distribution, and employee talents in a strategic market sector with outstanding growth potential. We expect our extensive product portfolio to strengthen and complement Fuse.”

“The prospect of combining the collective Fuse and CPM product portfolios is synergistic to both organizations,” commented Mr. Brooks.

About Fuse Medical, Inc.

Fuse provides a broad portfolio of orthopedic implants including internal and external fixation products; upper and lower extremity plating; total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; full spinal implants for trauma, degenerative disc disease, and deformity indications; human allografts, substitute bone materials, and tendons; and regenerative tissues and fluids to augment orthopedic surgeries and wound care. For more information about Fuse, please visit: www.fusemedical.com.

Forward-Looking Statements

Certain statements in this press release, including those related to an anticipated purchase of all of the outstanding membership units and plans for the consolidated company, 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 only on information available to the Company as of 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 failure of the Company to close the transaction; and integration issues with the consolidated company. 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.

Contacts

Fuse Medical, Inc.
Devon Peddie, 469-862-3030
Investor Relations Analyst
Facsimile 469-862-3035
info@Fusemedical.com

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