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.

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

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

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

http://news.cision.com/bone-index/r/bone-index-ltd–announces-american-medical-association-issues-new-reimbursement-code-for-bindex-oste,c2424125

The following files are available for download:

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SOURCE Bone Index

FDA permits marketing of device to treat diabetic foot ulcers

Posted On December 28, 2017 By OrthoSpineNews In Regulatory, Top Stories /

SILVER SPRING, Md., Dec. 28, 2017 /PRNewswire-USNewswire/ — Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection.

The Dermapace System is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2 (about the size of a soda can top) which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The Dermapace System is an external (extracorporeal) shock wave system that uses pulses of energy, similar to sound waves, to mechanically stimulate the wound. The device is intended for adult patients (22 years and older), presenting with diabetic foot ulcers lasting for more than 30 days, and should be used along with standard diabetic ulcer care.

The FDA reviewed clinical data from two multi-center, randomized, double-blind studies with a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement (removal of damaged tissue) as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy. Both patient groups included those with poorly controlled and well-controlled blood glucose levels.

The patients who had between one and seven treatments with the Dermapace System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period.

The most common side effects observed were pain during application of the device, local bruising and numbness, migraines, nausea, fainting, wound infection, infection beyond the wound (cellulitis, osteomyelitis) and fever.

The Dermapace System was reviewed through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type for which there is no legally marketed predicate device to which the device can claim substantial equivalence. This action also creates a new regulatory classification that would allow future devices to go through the FDA’s 510(k) process, whereby devices can demonstrate substantial equivalence to this predicate device.

The FDA permitted marketing of the Dermapace System to Sanuwave, Inc.

More information:

FDA: Recently Approved Devices

FDA: De novo pathway

FDA: Diabetes information for consumers

CDC: Diabetes

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Stephanie Caccomo, 301-348-1956, Stephanie.caccomo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

The Global Shoulder Arthroplasty Market is expected to reach $ 1,866.3 million by 2023

Posted On December 28, 2017 By OrthoSpineNews In Recon, Top Stories /

NEW YORK, Dec. 28, 2017 /PRNewswire/ — The Global Shoulder Arthroplasty Market was valued at $ 1,090.0 million in 2016, and is expected to reach $ 1,866.3 million by 2023, registering a CAGR of 8.1% during the forecast period. The growth of the global shoulder arthroplasty market is driven due to factors such as increasing incidences of arthritis-associated disorders such as osteoarthritis and rheumatoid arthritis, and growing geriatric population. Also, significant adoption of reverse shoulder arthroplasty by surgeons and growing sports-related injuries have further contributed to the growth of the market. Nevertheless, postoperative complications associated with shoulder arthroplasties and the cost associated with the shoulder arthroplasty devices is the factors that would limit the growth of the market.

Read the full report: https://www.reportlinker.com/p05258049

The shoulder arthroplasty market is segmented based on procedures, devices, indications, end users, and regions. Based on procedures, the market is segmented into partial shoulder arthroplasty, total shoulder arthroplasty, and revision shoulder arthroplasty. Based on devices, the market is segmented into shoulder arthroplasty resurfacing implants, shoulder arthroplasty trauma devices, and shoulder arthroplasty platform systems. Based on indications, the market is segmented into arthritis, fracture/dislocation, rotator cuff tear arthropathy, Hill Sachs defect, and others. Based on end users, the market is segmented into hospitals & clinics and outpatient surgical centers. Based on geography, the market is segmented into North America, Europe, Asia-Pacific, and LAMEA.

The market research report covers the analysis of key stake holders of the leading market participants are Integra LifeSciences Corporation, DJO Global, Zimmer Biomet, Wright Medical Group, Inc. /Tornier Inc., Johnson & Johnson (DePuy Synthes), Smith and Nephew Plc, Arthrex, Inc., Conmed Corporation, Evolutis, and Exactech, Inc.

Read the full report: https://www.reportlinker.com/p05258049

About Reportlinker
ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need – instantly, in one place.

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Contact Clare: clare@reportlinker.com
US: (339)-368-6001
Intl: +1 339-368-6001

SOURCE Reportlinker

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Middle East Medical Device Market – Expected to Reach $31.6 Billion by 2025

Posted On December 28, 2017 By OrthoSpineNews In Financial /

DUBLIN, Dec. 28, 2017 /PRNewswire/ —

The “Middle East Medical Device Market by Product (In Vitro Diagnostics (IVD), Cardiology, Orthopedics), by FDA classification (Class I, II, III), by End-user, by Region and Segment Forecasts, 2014 – 2025” report has been added to Research and Markets’ offering.

The Middle East medical devices market is expected to reach USD 31.6 billion by 2025. This growth is anticipated to be a result of increasing geriatric population, and increasing incidences of conventional diseases such as diabetes and obesity. Other major drivers include technological innovations and increasing demand and acceptance of such technologies in Middle Eastern countries majorly in UAE, Saudi Arabia and Qatar.

Furthermore, rising competitive pressure is witnessed in the Middle East medical device market as a result of high demand and low supply ratio. Hence, it can be predicted that the Middle East medical device market may witness lucrative growth over the forecast period.

Another factor responsible for this propelling growth is the supportive reimbursement pathways adapted by the Middle Eastern countries majorly to ensure quality healthcare provisions for every civilian. Major developments are witnessed in terms of regulatory structures as well, with an agenda to provide monetary benefits to the civilians and improve overall lifestyle of the people.

Further Key Findings From The Study Suggest:

Based on product type, In-Vitro Diagnostics(IVD) is expected to dominate the market as of 2016. Furthermore, neurology device segment is anticipated to grow at the fastest CAGR owing to the factors such as growing incidence of conventional diseases, augmenting research and technological advancement offered by key industry players to meet the current unmet needs.

The medical devices are also analyzed depending upon the U.S. FDA classification, with Class II being the dominant as well as the fastest growing segment during the forecast period. The Class II device segment is anticipated to capture over 60.0% of the market share by 2025.

Geographic expansion into Qatar, U.A.E. and Iraq by well-established players is anticipated to promote the fastest growth for the region.

Few of the industry players for the Middle East medical devices market include Medtronic, Johnson & Johnson, Siemens, Roche, Becton Dickinson and Abbott Laboratories.

Entry of various new players coupled with collaborative efforts by existing players is expected to be witnessed over the forecast period.

Key Topics Covered:

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Middle East Medical Device Market Variables, Trends & Scope

Chapter 4. Middle East Medical Device Market: Product Estimates & Trend Analysis

Chapter 5. Middle East Medical Device Market: FDA Classification Estimates & Trend Analysis

Chapter 6. Middle East Medical Device Market: End-use Estimates & Trend Analysis

Chapter 7. Middle East Medical Device Market: Regional Estimates & Trend Analysis

Chapter 8. Competitive Landscape

Medtronic
Johnson & Johnson
Siemens
Roche
Becton Dickinson
Abbott Laboratories
Novartis
Olympus Corporation
General Electric
Biomerica
Baxter International
Smith and Nephew
BioMrieux
Philips
Zimmer Biomet
For more information about this report visit https://www.researchandmarkets.com/research/vh9c5x/middle_east

Media Contact:

Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

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Global Artificial Joints Market 2017-2021: Driven by Increasing Demand for MI Surgeries – Research and Markets

Posted On December 27, 2017 By OrthoSpineNews In Recon /

December 27, 2017

DUBLIN–(BUSINESS WIRE)–The “Global Artificial Joints Market 2017-2021” report has been added to Research and Markets’offering.

The global artificial joints market is expected to grow at a CAGR of 5.53% during the period 2017-2021.

The report, Global Artificial Joints Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

One trend in the market is increasing demand for MI surgeries. The demand for MI surgeries has been increasing across the world. MI surgeries reduce physical trauma and the risk of infections. This enables patients to recover faster. MI surgeries involve short hospital stay, improve comfort, and enable the early return to work.

According to the report, one driver in the market is increasing incidence of age-related musculoskeletal disorders. Musculoskeletal disorders have been the most common disorder that affects the aging population. The most frequent musculoskeletal disorders among the aging population have been osteoporosis, osteoarthritis, fractures, and infections. With aging, musculoskeletal tissues become fragile, loose cartilage resilience, have reduced ligament elasticity, and loose of muscular strength, which reduce the ability of tissues to perform normal functions.

Key vendors

DePuy Synthes
Smith & Nephew
Stryker
Zimmer Biomet

Other prominent vendors

Arthrex
Acumed
Aesculap Implant Systems
AK Medical
BioPro
DJO Surgical
Extremity Medical
Others

Key Topics Covered:

Part 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Introduction

Part 05: Market Landscape

Part 06: Segmentation By Application

Part 07: Segmentation By Product Type

Part 08: Segmentation By End-User

Part 09: Segmentation By Geography

Part 10: Decision Framework

Part 11: Drivers And Challenges

Part 12: Market Trends

Part 13: Vendor Landscape

Part 14: Vendor Analysis

For more information about this report visit https://www.researchandmarkets.com/research/qjthg7/global_artificial

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Orthopedic Devices

Anika Announces FDA 510(k) Clearance for Its Injectable HA-Based Bone Repair Treatment

Posted On December 27, 2017 By OrthoSpineNews In Regulatory /

December 27, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that its HA-based bone void filler received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis), which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury. The bone void filler, which is composed of a synthetic, biocompatible bone graft substitute material, is injected into a void, hardens at body temperature, and is then resorbed and replaced by the growth of new bone during the healing process.

Over one million musculoskeletal procedures performed in the U.S. involve bone void filling, also known as bone grafting,^, and such procedures are most commonly required for spinal fusion, trauma, and revision total joint replacement procedures. We estimate the current market size for treating tibial plateau fractures, stress fractures around joints, and decompression of necrosed bone to be around $300 million.

“We’re proud to announce the U.S. regulatory clearance of our innovative injectable HA-based bone void filler, which represents the U.S. commercial debut of our robust regenerative medicine portfolio,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “The rapid 510(k) clearance is a testament to Anika’s operational and strategic expertise. In addition, this new treatment represents a promising revenue growth opportunity, and advances our mission to provide innovative treatments to patients that address the full continuum of orthopedic care.”

While the use of autologous bone or autograft has been the gold standard of treatment for bone grafting, the increased risk of procedural complications has prompted a shift towards alternate treatments¹, such as synthetic, resorbable bone graft substitute materials. According to Dr. John Tierney, D.O., an orthopedic surgeon affiliated with New England Baptist Hospital, who has worked with our bone repair treatment: “Anika’s 510(k) clearance allows for the marketing of one of only a handful of bone graft substitutes that can be administered in a minimally invasive manner. It offers physicians an additional option for treating bone defects or injuries, without the need for expensive and high risk surgeries, while also reducing the operating room time spent on each case.” This positive physician feedback enhances our excitement about bringing this much-needed treatment to patients in the U.S.

About Bone Repair Treatment

Anika’s bone repair treatment is an injectable, HA-based, settable osteoconductive calcium phosphate bone graft substitute material, and is indicated for filling bone voids or defects of the skeletal system (i.e., extremities and pelvis) that are not intrinsic to the stability of bone structure. It is provided in a kit with two components (an aqueous solution in a pre-loaded syringe and a dry powder) that must be mixed, intra-operatively using the supplied mixing system, to form a cohesive paste, prior to administration. Anika’s bone void filler is provided sterile for single use in volumes ranging from 1.5cc to 4cc.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC^®, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST^®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements

The statements made in the last sentence of the second paragraph and the last sentence of the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the potential market for, and revenue growth opportunity for the Company associated with, this product. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

¹ Marc Bohner, Resorbable biomaterials as bone graft substitutes, In Materials Today, Volume 13, Issues 1–2, 2010, Pages 24-30, ISSN 1369-7021, https://doi.org/10.1016/S1369-7021(10)70014-6. (http://www.sciencedirect.com/science/article/pii/S1369702110700146)

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
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Zimmer Biomet Announces Positive Results from PROGRESS II Trial of Autologous Protein Solution Prepared with nSTRIDE® APS Kit

Posted On December 26, 2017 By OrthoSpineNews In Sports Medicine /

WARSAW, Ind., Dec. 22, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the publication of positive results from a pilot study demonstrating the safety and promising efficacy of the nSTRIDE^® Autologous Protein Solution (APS) Kit for the treatment of knee osteoarthritis (OA). In the trial, known as PROGRESS II, investigators prepared APS by using Zimmer Biomet’s nSTRIDE APS Kit, which concentrates anti-inflammatory cytokines and growth factors from a sample of the patient’s own blood, for delivery via a single intra-articular injection into the knee joint. The results, which appeared in The American Journal of Sports Medicine¹, show significant improvement in the percentage change from baseline in pain scores measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), as well as comparable safety to saline.

OA, the most common type of arthritis, is a progressive disease of the joints. Often referred to as “wear and tear” arthritis, OA occurs when the top layer of cartilage, the slippery tissue that covers the ends of bones in a joint and helps absorb the shock of movement, breaks down and wears away. The bones under the cartilage then rub together, causing pain, swelling and loss of motion in that joint. Eventually, the joint may lose its normal shape and/or develop bone spurs around its edges.

“Inflammation is a critical factor in the pain and cartilage breakdown associated with knee osteoarthritis, and research has established that APS derived from the patient’s whole blood contains a host of powerful anti-inflammatory and anabolic proteins,” said Elizaveta Kon, MD, Associate Professor, Humanitas University, Milan, Italy, and lead investigator of the PROGRESS II trial. “After nearly a decade of preclinical and clinical research into the use of autologous anti-inflammatory cytokines and growth factors to treat osteoarthritis pain, we were pleased to demonstrate that APS, prepared with the nSTRIDE APS Kit, may be a promising, safe and viable new treatment for patients living with osteoarthritis of the knee.”

The PROGRESS II trial was a prospective, randomized, double-blind, saline-controlled pilot study that enrolled 46 patients with unilateral, mild-to-moderate, symptomatic knee OA pain from the four trial sites across Europe. Patients were randomized to receive either a single injection of APS prepared by the nSTRIDE APS Kit (n=31), or a single saline injection (n=15). Patient-reported outcomes and adverse events were assessed at two weeks, and at one, three, six and 12 months post-injection. Clinical effectiveness was measured using the Visual Analog Scale (VAS), the WOMAC, and the Knee Injury and Osteoarthritis Outcome Score (KOOS). X-ray and magnetic resonance imaging (MRI) evaluations were taken at baseline, as well as three and 12 months following treatment.

Top-line results showed that patients treated with APS demonstrated:

A 65 percent change in WOMAC pain score from baseline to 12 months compared to a 41 percent change in the saline group (p = 0.02).
A 49 percent improvement in VAS pain scores compared to a 13 percent improvement in the saline group (p = 0.06).
No procedure- or device-related serious adverse events, and comparable frequency, severity and relatedness of adverse events as compared to the saline group.

The nSTRIDE APS Kit is not commercially available in the United States but is currently marketed in Europe, via CE Mark, and in Japan, where it is marketed as the APS Kit. Results from the PROGRESS II study formed the basis for two additional confirmatory trials: the PROGRESS IV trial (NCT02905240), which received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in July 2016 and is currently enrolling patients, and the PROGRESS V trial (NCT03182374), which is underway in Europe to support global reimbursement efforts.

“As a global leader in musculoskeletal healthcare, Zimmer Biomet is committed to addressing the needs of patients along the entire continuum of care, from the management of symptoms like pain and stiffness with safe, non-invasive intra-articular injections like APS and Gel-One^®, to restoring joint function and mobility with our extensive portfolio of implant systems to treat advanced orthopaedic disease,” said David Nolan, Group President, Biologics, Extremities, Sports Medicine, Surgical, Trauma, Foot and Ankle, Office Based Technologies and Zimmer Biomet Signature Solutions. “The positive results of the PROGRESS II trial not only reinforce the safety and clinical value of the autologous anti-inflammatory protein solution prepared with the nSTRIDE APS Kit, but also lay the groundwork to advance our regulatory efforts in the United States and accelerate our commercial adoption and expansion in Europe and Asia-Pacific.”

About nSTRIDE APS
The nSTRIDE APS Kit is currently under clinical evaluation in the United States. It holds a CE Mark in Europe and is approved in Japan as the APS Kit. The device produces an anti-inflammatory-rich cellular solution from a patient’s own blood. The output of the nSTRIDE APS Kit contains white blood cells and their corresponding anti-inflammatory cytokines in concentrations much higher than that of whole blood, in addition to anabolic cytokines that may promote cartilage health.² These anti-inflammatory cytokines target and inhibit the pro-inflammatory and catabolic cytokines Interleukin-1 (IL-1) and Tumor Necrosis Factor Alpha (TNFα). Zimmer Biomet currently licenses the nSTRIDE APS technology to Owl Manor Veterinary, a privately held medical device company dedicated to joint preservation, tendon and ligament treatment, and advanced wound care treatment of equine and canine companion animals, under the brand name Pro-Stride Injection™. For more information, please visit http://www.omveterinary.com/.

References:

Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G Clinical outcomes of an autologous protein solution injection for knee osteoarthritis: a 1-year pilot double-blinded randomized controlled trial. Published in The American Journal of Sports Medicine, October 2017 [Epub ahead of print].
O’Shaughnessey K, Matuska A, Hoeppner J, et al. Autologous protein solution prepared from the blood of osteoarthritic patients contains an enhanced profile of anti-inflammatory cytokines and anabolic growth factors. J Orthop Res 2014;32(10):1349-55.

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

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

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

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

ZBH-Corp

SOURCE Zimmer Biomet Holdings, Inc.

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

Author: OrthoSpineNews

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