OrthoPediatrics Corp. Expands PediPlates® Franchise with Titanium System

WARSAW, Ind., Jan. 03, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce the launch of Titanium PediPlates®, the Company’s 24th surgical system. The titanium implant system expands OrthoPediatrics’ already comprehensive physeal tethering offering and includes both O-Plates and I-Plates as well as solid and cannulated low-profile screws. As a market leader in guided growth, OrthoPediatrics’ PediPlates technology harnesses the power of the growth plate through a simple, minimally invasive, and reversible tethering technique.

Joe Hauser, OrthoPediatrics’ Vice President of Trauma and Deformity Correction, noted that titanium PediPlates provide another correction option to pediatric orthopedic surgeons worldwide. “Adding a titanium offering to OrthoPediatrics’ market leading PediPlates physeal tethering franchise expands physicians’ treatment options, especially in patients who have a nickel allergy. The launch of our 24th surgical system strengthens our strategy to provide pediatric orthopedic surgeons with superior options for treating children.”

About PediPlates®
The PediPlates® system, which includes the I-Plate, O-Plate, and Delta Plate, provides a physeal tethering technique that does not disrupt the integrity of the physis, or growth plate. It features simple plate and screw constructs that span the growth center and restrain the physis by inhibiting growth where the plates and screws are applied. The system also features stainless steel plates and screws, which provide excellent strength, resistance to breakage, and ease of removal.

About OrthoPediatrics Corp. 
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 24 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

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

SAN DIEGOJan. 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.

Related Links

http://www.nuvasive.com

Zimmer Biomet Announces FDA Clearance of the Sidus® Stem-Free Shoulder System

WARSAW, Ind.Jan. 3, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced it has received U.S. Food and Drug Administration (FDA) clearance for the Sidus® Stem-Free Shoulder system as a total shoulder arthroplasty solution for patients with good bone stock that have either osteoarthritis, post-traumatic arthrosis, focal avascular necrosis of the humeral head or who had previous surgeries of the shoulder that do not compromise the fixation. The Sidus Stem-Free Shoulder system is designed to anatomically restore a patient’s anatomy, preserve bone stock and allow for improved pre to post-operative patient outcomes1,2. The Sidus system will be available in the United States beginning in the First Quarter of 2018.

“The Sidus Stem-Free Shoulder system offers a novel approach to total shoulder arthroplasty requiring minimal bone resection,” said Dr. Ryan Krupp, orthopaedic surgeon at Norton Orthopedic Specialists in Louisville, Ky. “The Sidus system is designed to reduce pain and restore range of motion and is clinically proven to help suitable patients.”1,2

“The FDA clearance of the Sidus Stem-Free Shoulder system comes at a time when Zimmer Biomet is accelerating the pace of innovation,” said Bryan C. Hanson, Zimmer Biomet President and Chief Executive Officer. “We launched Sidus in Europe in 2012 and initiated a clinical study in the U.S. in 2015. During that time, the product has demonstrated strong clinical performance. The addition of the Sidus system to Zimmer Biomet’s U.S. portfolio reinforces the Company’s leadership in the innovation of shoulder solutions.”

About Zimmer Biomet

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

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

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

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

ZBH-Corp

1 Multicenter Trial of the Sidus® Stem-Free Shoulder Arthroplasty System (Protocol CIU2012-12E/G130026, “IDE”).

2 Sidus® Stem-Free Shoulder: A Multicenter, Prospective, Non-Controlled Post Market Clinical Follow-up Study (Clinical Investigation Plan CME2012-01E, “PMCF”).

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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

LOS ANGELESJan. 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.

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

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.

Related Links

http://www.zyga.com

WishBone Medical, Inc. Releases Broken Screw Removal and K-Wire Systems

WARSAW, Ind., Jan. 02, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc., a new global pediatric orthopedic company, has announced the official launch of the single-use, sterile packed Broken Screw Removal and K-Wire Systems.  The Broken Screw Removal System is available in three different sizes: 2.7mm, 3.5mm and 4.5mm and is designed to remove broken, stripped and cold-welded screws.

The K-Wire Systems are available in five different configurations; Pediatric Elbow Combo Kit (1.6mm & 2.0mm K-Wires), Pediatric Long Bone Combo Kit (2.0mm & 2.5mm K-Wires), Three Pediatric Extremity Combo Kits; Small (0.7mm & 0.9mm K-Wires), Medium (0.9mm & 1.25mm K-Wires) and Large (1.25mm & 1.6mm K-Wires). Each system includes two different sizes of wires, protective pin covers and instruments.

Nick Deeter, WishBone Medical’s Founder and CEO added, “The Broken Screw Removal and K-Wire Systems both address current issues that Pediatric Surgeons face with their small patients. They need products that are sterile, easy to find, easy to use and designed for pediatric patients. We strongly believe that having these products readily available in sterile packed, single-use kits will be a game changer in the operating room.”

To learn more about WishBone Medical, visit www.WishBoneMedical.com

About WishBone Medical, Inc.

WishBone Medical, a Global pediatric orthopedic company, is committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits, to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing.

For more information, contact Andrew Miclot, Vice Chairman and President, at 574-306-4006 or email CustomerService@WishBoneMedical.com

ApiFix Ltd. Announces New Leadership

Misgav, Israel – 2 January 2018 –ApiFix Ltd. (“ApiFix”), a portfolio company of The TrendlinesGroup 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

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

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2018 SI-BONE, Inc. All Rights Reserved. 10037.010218

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.

Related Links
http://www.si-bone.com

Bone Index Ltd. Announces AMA Issues New Reimbursement Code for Bindex Osteoporosis Measurement

HELSINKI, Jan. 2, 2018 /PRNewswire/ — Bone Index Ltd., one of Europe’s top new manufacturers of medical devices, announces that the American Medical Association (AMA) has issued a new Category III CPT® code* for Bindex® measurement to help physicians in diagnosing osteoporosis.

“In osteoporosis screening and diagnostics area, it has taken about 20 years since the last new code and therefore this new CPT code is a huge step for healthcare operators to provide highly needed osteoporosis examinations. This is also very strong evidence that Bindex is a new and unique medical device which provides significant improvement in osteoporosis screening and diagnostics in US,” says Bone Index’s CEO, Dr. Ossi Riekkinen.

Bindex® point-of-care device measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA. Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.

Undiagnosed osteoporosis is a worldwide challenge. In the US alone osteoporosis is responsible for two million broken bones every year, costing over 19 billion dollars. Experts forecast that by 2025, the costs will rise to 25.3 billion dollars. One of the biggest challenges is the limited availability of osteoporosis diagnostics since bone density scans are mostly performed in hospitals with large DXA X-ray machines that entail high costs. “This is why Bindex® is a game-changer,” says Dr. Riekkinen.

Bindex® has a total of 19 patents globally including the US, China, Japan and large European countries. “Now Bindex is used by the US’s leading provider of direct to consumer preventive health screenings, Life Line Screening, and in addition, for example, neurosurgeries are using Bindex as a pre-operative measurement. The overall aim is to prevent osteoporotic fractures and improve the quality of life for families in the US,” Dr. Riekkinen concludes.

For more information:

Bone Index Ltd.
Dr. Ossi Riekkinen
CEO
ossi.riekkinen@boneindex.fi
+358-50-363-2797
www.bindex.fi/en/

*0508T: Pulse-echo ultrasound bone density measurement resulting in indicator of axial bone mineral density, tibia. Effective date July 1, 2018. https://www.ama-assn.org/sites/default/files/media-browser/public/cpt/cpt-category3-codes-descriptors.pdf

About Bone Index:

Founded in 2011 and based in Kuopio, Bone Index Finland Ltd. specializes in the development of measuring devices for osteoporosis screening and diagnosis.

This information was brought to you by Cision http://news.cision.com

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SOURCE Bone Index

Related Links
http://www.bindex.fi/en/