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3D Printed Medical Devices Market is projected to be valued at US$ 1469.4 million by the end of 2026

Posted On May 23, 2017 By OrthoSpineNews In Financial /  

NEW YORK, May 23, 2017 /PRNewswire/ —

Highlights 

·         3D printed medical devices are state-of-the-art medical devices that involve a process of developing three dimensional solid objects from a digital model.

·         Patient specific treatment is the main advantage of 3D printing technology in the healthcare industry.

·         In the domain of healthcare, 3D printing technology is used to develop medical devices such as dental implants, orthopaedic implants, prosthetics, and hearing aids.

·         In terms of revenue, the global 3D printed medical devices market is anticipated to grow at a CAGR of 17.7% during the forecast period and is projected to be valued at US$ 1469.4 million by the end of 2026.

·         However, relatively low adoption of 3D printing technology and regulatory considerations may hinder the growth of the 3D printed medical devices market over the forecast period.

3D printed medical devices are state-of-the-art medical devices that involve a process of developing three dimensional solid objects from a digital model. Patient specific treatment is the main advantage of 3D printing technology in the healthcare industry. In the domain of healthcare, 3D printing technology is used to develop medical devices such as dental implants, orthopaedic implants, prosthetics, and hearing aids. Furthermore, hospitals and academic institutes use 3D printing technology to develop various models for training purposes. 3D printed medical devices considered in the report typically use technologies such as stereolithography (SLA), selective layer sintering (SLS), digital light processing (DLP), fused deposition modelling (FDM), polyjet / inkjet 3D printing, and electronic beam melting (EBM).

In terms of revenue, the global 3D printed medical devices market is anticipated to grow at a CAGR of 17.7% during the forecast period and is projected to be valued at US$ 1469.4 million by the end of 2026.

Increasing geriatric population and a rise in the number of accidents is fuelling the global market for 3D printed medical devices

Growth of the global 3D printed medical devices market is principally driven by increasing geriatric population across the globe, thus increasing the risk of diabetes-related gangrene cases, peripheral vascular disease, and osteoarthritis among elderly individuals. Additionally, increasing incidence of accidents due to rapid modernisation, use of fast moving machinery, and increasing prevalence of chronic diseases is expected to fuel market growth over the forecast period. However, relatively low adoption of 3D printing technology and regulatory considerations may hinder the growth of the 3D printed medical devices market over the forecast period.

Market Segmentation
By Material

By Application

By Technology

By Distribution Channel

By Region

Plastics

Thermoplastics

Photopolymers

Biomaterial Inks

Polymers

Ceramics

Hydrogels

Metals and Alloys

Orthopaedic Implants

Dental Implants

Cranio-maxillofacial Implants

Internal and External Prostheses

Stereolithography (SLA) – Liquid

Based 3D Printing

Selective Laser Sintering (SLS) –Powder Based 3D Printing

Digital Light Processing(DLP)

Fused Deposition Modeling (FDM): Plastic Filament Extrusion Based Technology

Electronic Beam Melting (EBM)

PolyJet / InkJet 3D Printing

Hospitals

Diagnostic Centers

Ambulatory Surgical Centres (ASCs)

North America

Latin America

Western Europe

Eastern Europe

APEJ

Japan

Middle East and Africa (MEA)

The plastics segment is expected to remain dominant throughout the forecast period

In terms of revenue share, the plastics material segment dominated the global 3D printed medical devices market in 2015 and is expected to dominate throughout the forecast period. The plastics segment is expected to account for 72.0% market share of the global 3D printed medical devices market in 2016. In terms of value, the biomaterial Inks segment is expected to register the highest CAGR of 20.1 % during the forecast period.

Orthopaedic segment is the largest segment by application

In terms of revenue share, the orthopaedic implants application segment dominated the global 3D printed medical devices market in 2015 and is expected to dominate throughout the forecast period, registering a higher CAGR as compared to other application type segments. The orthopaedic segment is expected to account for 19.9% market share of the global 3D printed medical devices market in 2016.

Polyjet/Inkjet 3D printing to be the dominant segment by technology type

In terms of revenue share, the SLS technology segment dominated the global 3D printed medical devices market in 2015 whereas the polyJet / inkJet 3D printing segment is expected to dominate throughout the forecast period, registering a steady CAGR.

Hospital segment is the largest segment as per the distribution channel segment
In 2016, the hospital segment is estimated to account for the highest market share, expected to reach a value of US$ 862.1 Mn by 2026, and is anticipated to remain the dominant segment during the forecast period.

North America to be the largest market for 3D printed medical devices

In terms of value, North America is expected to be the dominant regional market by 2016 end, and is expected to register a CAGR of 19.2% over the forecast period. Western Europe is expected to be the second fastest growing market registering a CAGR of 18.5% over the forecast period followed by Eastern Europe, APEJ, and Japan.

global 3D printed medical devices market

Key players
are focussing on introducing innovative marketing strategies to increase their market share

Read the full report: http://www.reportlinker.com/p04394425/3D-Printed-Medical-Devices-Market-Global-Industry-Analysis-Opportunity-Assessment-.html

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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Photo Posted in 3D Printing Technology

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United Orthopedic Corporation Announces First Patient Enrollment In Study Of U2 Knee™ System

Posted On May 23, 2017 By OrthoSpineNews In Recon /  

IRVINE, Calif., May 23, 2017 /PRNewswire/ — United Orthopedic Corporation (UOC), a leading international designer, manufacturer and distributor of innovative orthopedic implants and instruments, today announced the launch of a primary total knee arthroplasty (TKA) trial. Entitled “Prospective Post Approval Clinical Follow-Up Study of the Commercially Available U2 Knee™ System – ‘U Propel Study’,” the trial recently enrolled its first patient. This prospective, single arm, multi-center, post-market study will evaluate the short- and long-term clinical performance, and implant survivorship of the commercially available U2 Knee™ System in subjects receiving primary TKA.

“We were extremely confident with the execution and success of the first U2 Knee System replacement,” said David Cashen, MD, principal study investigator and practicing orthopedic surgeon at Coastal Orthopedics in Bradenton, Fla. “One day after surgery our patient is ambulating independently, performing a straight leg raise and confident to return home with only mild discomfort. We look forward to monitoring her recovery through our research.”

The U-Propel study will enroll up to 200 patients. Patients will participate in baseline, pre-discharge, six-week, three, six and 12-month, as well as annual follow-up visits for up to five years. The study’s primary endpoint is implant survivorship. The secondary endpoints are Knee Society Score; radiographic success; subject satisfaction; KOOS, Jr.; EQ-5D and operative characteristics. The expected duration of the study is seven years.

“For more than two decades, our company has been engaged in helping orthopedic surgeons deliver high-quality care to their patients, providing them with innovative products designed to improve patient health and satisfaction,” said Calvin Lin, President of United Orthopedic Corporation USA. “The U-Propel study underscores our continued commitment to orthopedic care, building upon our foundation of research that demonstrates the value of our solutions.”

Outcomes from the U-Propel study will be analyzed and published in three phases as follows: after all enrolled patients have completed their six-week follow-up; at the two-year follow-up mark; and at the conclusion of the study. In addition to Dr. Cashen and the team of surgeons at Coastal Orthopedics, George Markovich, MD, is also an orthopedic surgeon and study investigator. Dr. Markovich is from the Institute for Orthopaedic Surgery and Sports Medicine in Fort Myers, Fla.

Osteoarthritis is a common disease of the aging demographic and a leading cause of disability, with the incidence of knee osteoarthritis rising with the increasing average age of the general population.1 Approximately 10 percent of people aged over 55 years have painful disabling knee osteoarthritis, of whom one quarter are severely disabled.1  TKA is one of the treatment options available to sufferers of knee osteoarthritis.

For more information about the U-Propel study, visit: https://clinicaltrials.gov/ct2/show/study/NCT03060057

UOC is actively recruiting qualified surgeons and their institutions who would like to participate in this post-market study. Please contact Mindy Carlson, Director of Clinical Research, at mindy.carlson@uocusa.com, or 612-562-0060, to inquire.

About United Orthopedic Corporation
United Orthopedic Corporation (UOC) is a leading international designer, manufacturer, and distributor of innovative, regulatory compliant orthopedic implants and instrument sets used by surgeons around the globe. UOC’s offering includes a flexible range of clinically proven solutions used to perform total hip/knee replacements and revisions, plus clinical education, service and support for surgeons and hospital staff. UOC operates Quality Management Systems (QMS) that comply with ISO 9001/13485, FDA, and CE requirements. For more information about United Orthopedic Corporation, visit www.uocusa.com.

Media Contact
Erich Sandoval
Lazar Partners Ltd.
Tel: +1 917-497-2867
Email: esandoval@lazarpartners.com
_________________________________
1 Heidari B. Knee osteoarthritis prevalence, risk factors, pathogenesis and features: Part I. Caspian Journal of Internal Medicine. 2011;2(2):205-212.

SOURCE United Orthopedic Corporation

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http://www.uocusa.com

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Anika Announces Publication of Phase III Data Demonstrating the Efficacy and Safety of CINGAL®

Posted On May 23, 2017 By OrthoSpineNews In Extremities /  

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the publication of Phase III data demonstrating the efficacy and safety of CINGAL®, its novel HA-corticosteroid combination viscosupplement for the treatment of symptoms associated with osteoarthritis (“OA”) of the knee. The data, published in this month’s issue of the peer-reviewed journal Cartilage, demonstrated that CINGAL provided superior immediate and short term pain relief after injection as compared to HA alone, and superior relief from OA-related pain, stiffness and function through 26 weeks as compared to saline. These Phase III study results were part of the comprehensive clinical data package that formed the basis for CINGAL’s CE Mark and Health Canada approval in 2016.

“We are excited to share published, peer-reviewed Phase III data that validates the efficacy, safety and clinical significance of our novel viscosupplement, CINGAL,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer of Anika Therapeutics. “CINGAL fulfills a tremendous unmet clinical need for a low-volume corticosteroid and hyaluronic acid combination viscosupplement that has an established track record of safety and efficacy, and provides immediate and long-term relief from knee OA symptoms for 6 months and potentially beyond.”

CINGAL is the first and only viscosupplement that combines triamcinolone hexacetonide, a well-established, FDA-approved steroid that may be utilized to treat inflammation, with Anika’s proprietary cross-linked, non-animal-derived hyaluronic acid, which is the active “cushioning” ingredient in the global market-leading viscosupplements, ORTHOVISC® and MONOVISC®. Viscosupplements are injected by a licensed medical professional into synovial joints to replenish the natural cushioning within joints that depletes with age and degenerative orthopedic diseases, causing pain.

The multicenter, double-blind, saline-controlled clinical trial evaluated 368 patients with knee osteoarthritis who were randomized for treatment with a single injection of CINGAL (n=149), MONOVISC (n=150) or saline (n=69). Changes in pain, stiffness and physical function were assessed using a variety of validated measurement tools including the Western Ontario and McMaster Universities Arthritis Index (WOMAC)1.

Below are the key findings:

  • CINGAL reduced WOMAC Pain by 70% at 12 weeks and 72% at 26 weeks as compared to saline – more improvement than that reported in previous viscosupplement studies.2, 3, 4, 5
  • CINGAL demonstrated rapid pain relief following administration (a 59% improvement in WOMAC Pain at 1 week and 68% at 3 weeks) – unmatched by prior trials of triamcinolone hexacetonide alone.6, 7
  • CINGAL met all primary and secondary endpoints relative to saline in the ITT analysis.
  • CINGAL demonstrated significant improvement with respect to most secondary endpoints for pain and function at most time points through 26 weeks.
  • At 1 and 3 weeks, CINGAL was significantly better than MONOVISC for most endpoints.
  • CINGAL and MONOVISC provided similar benefits from 6 weeks through 26 weeks.
  • CINGAL was shown to be safe, and was associated with a low incidence of adverse events (n=6) that resolved over time. There were no serious adverse events considered to be related to CINGAL.

“Steroid injections and hyaluronic acid-based viscosupplements are two forms of effective non-surgical interventions to manage knee osteoarthritis,” said Prof. Laszlo Hangody, MD, Ph.D., DSc., the study’s lead author, Clinical Professor at the Debrecen Medical School and Senior Consultant in the Orthopaedic Department at Uzsoki Hospital, Budapest, Hungary. “By combining a proven viscosupplement, MONOVISC, with an established steroid in a single injection, CINGAL gives patients a safe, convenient and highly effective treatment option for immediate and sustained relief from the debilitating symptoms of knee OA.”

CINGAL is commercially available in certain countries of the European Union (E.U.), and Canada, and is under regulatory review in the United States. Anika recently completed site initiation in the E.U. to begin enrolling patients in a supplemental Phase III study requested by the U.S. Food and Drug Administration. Anika anticipates FDA approval of CINGAL after it completes the study in 2018.

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 third sentence of the final 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 Company’s expectations regarding the Company’s supplemental Phase III study for CINGAL and FDA approval of CINGAL. 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 Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness and physical functioning of the joints.
2 Chevalier X, Jerosch J, Goupille P, van DN, Luyten FP, Scott DL, et al. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis 2010;69:113-119
3 Strand V, Baraf HS, Lavin PT, Lim S, Hosokawa H. A multicenter, randomized controlled trial comparing a single intra-articular injection of Gel-200, a new cross-linked formulation of hyaluronic acid, to phosphate buffered saline for treatment of osteoarthritis of the knee. Osteoarthritis Cartilage 2012;20:350-356
4 Karlsson J, Sjogren LS, Lohmander LS. Comparison of two hyaluronan drugs and placebo in patients with knee osteoarthritis. A controlled, randomized, double-blind, parallel-design multicentre study. Rheumatology 2002;41:1240-1248
5 Neustadt D, Caldwell J, Bell M, Wade J, Gimbel J. Clinical effects of intraarticular injection of high molecular weight hyaluronan (Orthovisc) in osteoarthritis of the knee: a randomized, controlled, multicenter trial. J Rheumatol 2005;32:1928-1936
6 Pyne D, Ioannou Y, Mootoo R, Bhanji A. Intra-articular steroids in knee osteoarthritis: a comparative study of triamcinolone hexacetonide and methylprednisolone acetate. Clin Rheumatol 2004;23:116-120
7 Frias G, Caracuel MA, Escudero A, Rumbao J, Perez-Gujo V, del Carmen CM, et al. Assessment of the efficacy of joint lavage versus joint lavage plus corticoids in patients with osteoarthritis of the knee. Curr Med Res Opin 2004;20:861-867

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Susan Heins, 864-286-9597

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Anika Celebrates 25th Anniversary and Inaugurates Newly Expanded Global Manufacturing Facility

Posted On May 23, 2017 By OrthoSpineNews In Biologics /  

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, is hosting a celebration today at its Bedford, Massachusetts headquarters to commemorate its 25th anniversary and inaugurate its newly-expanded and consolidated global manufacturing facility. Previously, Anika’s manufacturing operations were split between its U.S. headquarters and a contract manufacturer in Abano Terme, Italy, but the company initiated plans to onshore manufacturing in the U.S. to maintain better control of supply chain, accelerate product development, and increase operating efficiency. By year end, our 134,000 square foot corporate headquarters and the newly expanded state-of-the-art facility will manufacture and package the totality of the company’s diverse portfolio of more than 20 products for distribution into more than 55 markets across the globe.

“We are proud and excited to consolidate our entire manufacturing operation in the United States on the 25th anniversary of our inception,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer, Anika Therapeutics. “The new facility not only helps Anika more deftly manage global supply and inventory, but it also creates opportunities for a highly-skilled workforce, and brings sophisticated scientific capabilities and cutting-edge technologies back to the U.S. and to the state of Massachusetts, which has been a steadfast and supportive partner throughout our 25-year journey.”

Anika develops, manufactures and commercializes a diverse range of therapeutic products, the large majority of which are based on its proprietary formulation of non-animal-derived HA, a naturally occurring substance in the human body with lubricating, healing, restorative and regenerative properties. In the Bedford-based manufacturing facility, Anika utilizes proprietary processes to produce its suite of unique gel-based and textile-form products from highly-concentrated and ultra-pure HA. Anika’s Bedford-based manufacturing facility and corporate headquarters employs approximately 100 operations, engineering, clinical, assembly, warehouse, marketing, general and administrative professionals, and it is the only facility in the U.S. with the sophisticated capability to produce HA products in solid textile forms.

“We welcome Anika Therapeutics’ decision to bring its healthcare manufacturing sector back to the U.S. and to the Commonwealth as they celebrate 25 years supporting our local economy,” said Governor Charlie Baker. “Our strong and talented workforce is helping businesses large and small thrive, supporting economic growth and new jobs across Massachusetts.”

“For 25 years Anika Therapeutics has provided value and stability to not just the life sciences industry, but the Commonwealth as a whole. With this upcoming expansion, the anticipated and sustained impact on the local and state economy cannot be overstated,” Travis McCready, President & CEO of the Massachusetts Life Sciences Center said. “On behalf of the Massachusetts Life Sciences Center, I congratulate Anika on these first 25 years, and look forward to their continued success for the next quarter century and beyond, here in Massachusetts.”

“Congratulations to Anika and its leadership on celebrating 25 years of success and growth,” said Robert K. Coughlin, CEO and President of MassBio. “Their longevity and commitment to innovation is a shining example for other Massachusetts companies who are looking to follow their lead.”

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 first 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 Company’s expectations regarding 2017 production capabilities. 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.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Susan Heins, 864-286-9597

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OrthoMemphis Performs First Meniscus Replacement in Tennessee with NUsurface® Implant

Posted On May 23, 2017 By OrthoSpineNews In Sports Medicine /  

MEMPHIS, Tenn.–(BUSINESS WIRE)–OrthoMemphis and Active Implants, a Memphis-based company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedure in Tennessee was successfully performed.

Dr. Randall Holcomb, sports medicine orthopaedic surgeon and president of OrthoMemphis, was the surgeon selected for the study due to his 30 years of expertise in area of cartilage restoration and transplantation. OrthoMemphis is the only center in Tennessee – and just one of 10 sites nationwide – participating in the VENUS (Verification of the Effectiveness of the NUsurface® System) clinical trial, which is enrolling patients with persistent knee pain after loss of meniscus cartilage to assess the safety and effectiveness of the investigational NUsurface Meniscus Implant compared to non-surgical standard of care.

The meniscus is a tissue pad between the thigh and shin bones. Once it is damaged, the meniscus has a very limited ability to heal, and therefore meniscus surgery is performed to remove the torn painful portion of the meniscus. Over 1 million partial meniscectomies are performed in the U.S. every year, more than the total number of hip and knee replacement surgeries combined. While partial meniscectomy surgery is tremendously successful, there is still a subset of patients that continue to experience pain following meniscal surgery. These patients tend to have deteriorating meniscus cartilage, which remains painful and can evolve into arthritis requiring a total knee replacement.

The first patient to receive the NUsurface Meniscus Implant in Tennessee is Memphis resident Dr. Tim Goldsmith. He suffered a knee injury two years ago while practicing twisting lunges during a workout session. This injury led the 60-year-old to undergo alternative treatments to treat the pain, including muscle strengthening physical therapy, injections to relieve pain and finally a partial meniscectomy on his left knee. However, he continued to have consistent knee pain on a daily basis that impacted any activity – from playing golf and interval workout training classes to simply walking up and down stairs.

“There are few options for patients who experience persistent knee pain following meniscus surgery,” Dr. Holcomb said. “We hope the NUsurface implant will act as an artificial meniscus to alleviate their pain and hopefully prevent the onset of degenerative joint disease. Although at this time we cannot make the claim, the NUsurface device may be the solution to slowing down or preventing degenerative arthritis associated with meniscal injuries.”

Dr. Holcomb implanted the device in April 2016 through a small incision in Goldsmith’s knee. Goldsmith was able to quickly return to his work as chief clinical officer at Youth Villages, a private nonprofit dedicated to helping thousands of emotionally and behaviorally troubled children and their families live successfully. Following the full six-week physical therapy regimen with OrthoMemphis’ Steven Chipman,Goldsmith also resumed his favorite pastimes, including golf, spin classes, and interval strength and resistance training. Since his surgery, Goldsmith’s knee has been stable and he has continued his active lifestyle.

“Prior to receiving the NUsurface Meniscus Implant, I felt like I was out of options and had resigned myself to living with pain and waiting for eventual knee replacement,” Goldsmith said. “Now, I am not only rid of the knee pain, but am also experiencing better mobility and flexibility – this gives me hope that I will have the ability to stay as active as I’d like to be for as long as I can.”

The NUsurface Meniscus Implant is inserted into the knee joint through a small incision, and patients typically can go home on the same day of the operation. After surgery, they undergo a six-week rehabilitation program. NUsurface has been used in Europe since 2008 and Israel since 2011.

About the Clinical Trial

As part of the process to gain regulatory approval in the U.S., the VENUS (Verification of the Effectiveness of the NUsurface® System) study will enroll approximately 130 patients at orthopedic centers in the U.S., Europe and Israel. Sites in the U.S. include Indiana (Indianapolis), Massachusetts (Boston), New York (Albany, Rochester and New York), North Carolina (Durham), Ohio (Columbus), Tennessee (Memphis) and Virginia (Richmond). Participants who meet study requirements and agree to enter the trial are randomized to receive either the NUsurface device or non-surgical treatment, which is the current standard of care for patients with persistent knee pain following meniscus surgery. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the VENUS study, please call (844) 680-8951 or visit www.meniscus-trial.com.

About the NUsurface® Meniscus Implant

In the U.S., the NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. The NUsurface Meniscus Implant is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. The NUsurface device mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. It is inserted into the knee joint through a small incision, and patients typically can go home soon after the operation. After surgery, patients undergo a six-week rehabilitation program. The NUsurface device has been used clinically in Europe since 2008 and Israel since 2011.

About OrthoMemphis

OrthoMemphis’ team of 18 doctors provides surgical and non-surgical treatment in general orthopedic and subspecialty areas of sports medicine, spine, hand, foot & ankle, hip & knee, total joint replacement, treatments of bone and soft tumors of the extremities (benign and malignant) in children and adults, and workers’ compensation injuries. Fellowship trained surgeons provide expert care in each subspecialty. For more information, go to http://www.orthomemphis.com/.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in The Netherlands, with R&D facilities in Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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CollPlant Signs New Exclusive Distribution Agreement in Turkey for Vergenix®FG Wound Treatment

Posted On May 23, 2017 By OrthoSpineNews In Biologics, Top Stories /  

NES ZIONA, Israel, May 22, 2017 /PRNewswire/ — CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human “rhCollagen”) technology for tissue repair products announced that the Company has signed a new, exclusive distributor agreement in Turkey to market Vergenix®FG, for the treatment of chronic wounds. The one year agreement includes a two-year extension option. The market potential for the treatment of chronic wounds in Turkey is estimated at in excess of 400,000 procedures annually.

Yehiel Tal, Chief Executive Officer of CollPlant, noted, “We have received excellent feedback from opinion leaders in Europe who have been using the product, and the signing of the agreement with the Turkish distributor represents a further layer in the implementation of the Company’s sales strategy on the continent. Our objective is to build up the sales infrastructure for Vergenix®FG through distributors in various, key territories.”

Below is a link to a video review by Professor Alberto Piaggesi, M.D., Director of the Diabetic Foot Section of the Pisa University Hospital, Italy and a member of the Council of the European Wound Management Association (EWMA). Dr. Piaggesi, who uses Vergenix®FG to treat patients with hard to heal chronic wounds, describes the product’s advantages and its success in closing wounds. (Warning: the video includes pictures from treatment that some viewers might find distressing).

CollPlant Vergenix FG – Prop. Alberto Piaggesi – Youtube

About Vergenix®FG

Vergenix®FG is an injectable gel compound based on the Company’s human collagen, which has shown to treat chronic wounds and operation-based incisions, including diabetic foot ulcer. The gel is injected directly into the wound, thereby filling it and facilitating a healing process through to complete wound closure, without any side effects such as infections or allergies which may occur with other treatment options.

About CollPlant

CollPlant is a regenerative medicine company leveraging its proprietary, plant-based recombinant human collagen (rhCollagen) technology for the development and commercialization of tissue repair products, initially for the orthobiologics, 3D Bio-printing of tissue and organs, and advanced wound care markets. The Company’s cutting-edge technology is designed to generate and process proprietary rhCollagen, among other patent-protected recombinant proteins. Given that CollPlant’s rhCollagen is identical to the type I collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. The Company’s broad development pipeline includes biomaterials indicated for orthopedics and advanced wound healing. Lead products include: Vergenix®STR (Soft Tissue Repair Matrix), for the treatment of tendinopathy; and Vergenix®FG (Flowable Gel) wound filler, for treatment of acute and chronic wounds. CollPlant’s business strategy includes proprietary development and manufacture of tissue repair products and their commercialization and distribution, together with leading third parties, alongside alliances with leading companies for joint development, manufacture and marketing of additional products.

For more information about CollPlant, visit http://www.collplant.com

Contact at CollPlant:                                   

Eran Rotem
Chief Financial Officer
Tel: + 972-73-2325600/612
Email: Eran@collplant.com

Contact at Rx Communications Group, LLC:

Paula Schwartz (for US Investors)
Managing Director
Tel: 917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

Related Links

http://www.collplant.com

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Organogenesis Closes on a $20 Million Facility from Eastward Capital Partners

Posted On May 23, 2017 By OrthoSpineNews In Biologics, Financial, Top Stories /  

CANTON, Mass., May 22, 2017 /PRNewswire/ — Organogenesis Inc., a commercial leader in the field of regenerative medicine focusing on advanced wound care and surgical biologics, today closed a $20 million financing facility with Eastward Capital Partners, a leading provider of venture debt and equity financing to technology companies.

“We were fortunate to have several choices in a financing partner as we continue to build our balance sheet and our product portfolio to provide the most advanced wound care and surgical biologics solutions to our customers,” said Tim Cunningham, Chief Financial Officer of Organogenesis Inc. “We chose Eastward Capital Partners given their impeccable credentials and stellar reputation, which aligns well with Organogenesis’ core values.  Additionally, Eastward Capital Partners has decades of experience financing health technology companies and understands the value our products bring to clinicians and patients.”

“Eastward Capital Partners is committed to partnering with technology-forward companies who are leaders in their industry segments,” said Eastward Partner’s Tim O’Loughlin. “We are excited to partner with Organogenesis to provide the capital to support their growth plans.”

About Organogenesis Inc.
Originally founded as a spin-off from technology developed at MIT in 1985, Massachusetts-based Organogenesis Inc. is a global leader in regenerative medicine, offering a portfolio of bioactive and acellular biomaterials products for advanced wound care, orthopedics, and spine. Organogenesis’ versatile portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com.

About Eastward Capital Partners
Eastward has provided private debt to leading companies in the Information Technology, Communications, New Media and Healthcare sectors since 1994.  As one of the oldest and most respected investors in the market, Eastward has a long history of working with companies to craft funding solutions which allow companies to reach their full potential.  www.eastwardcp.com

CONTACT:
Angelyn Lowe
(781) 830-2353
alowe@organo.com

SOURCE Organogenesis Inc.

Related Links

http://organogenesis.com/

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NuVasive Announces Educational Initiatives In Support Of Spine’s Fastest Growing Spinal Deformity Portfolio

Posted On May 23, 2017 By OrthoSpineNews In Spine /  

SAN DIEGO, May 22, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company’s increased investment and support of adult and pediatric deformity research, education, and awareness initiatives throughout 2017.

NuVasive increased its focus on the $2.5 billion deformity market in May 2015 with the launch of its Integrated Global Alignment® (iGA®) platform and RELINE® posterior fixation system. In February 2016, NuVasive expanded its footprint into the early onset scoliosis market with the addition of its industry-leading MAGEC® system, which utilizes innovative magnetic technology within adjustable growing rods. Today, NuVasive has the fastest growing spinal deformity portfolio and is expanding its support of key programs to drive improved clinical and economic outcomes. NuVasive recently launched the ‘Embracing the Journey Together‘ program, which includes pediatric spinal deformity research, education and spinal deformity event support, supporting leading surgeons as they educate surgeons around the world.

“At NuVasive, we remain laser-focused on transforming the lives of patients through disruptive innovation and support of clinical education and research,” said Greg Lucier, NuVasive chairman and chief executive officer. “We’ve made tremendous gains in adult and pediatric spinal deformity innovation, with the versatile RELINE portfolio and MAGEC system. With the upcoming launch of the RELINE Small Stature system available this summer, I’m confident in our ability to outpace the market. We’re proud NuVasive has taken the lead in supporting key global initiatives designed to help improve the lives of patients around the world.”

Part of the Company’s investment into pediatric spinal deformity care includes funding research and patient initiatives, such as the Harms Study Group and its Setting Scoliosis Straight Foundation, as the exclusive sponsor of the Power Over Scoliosis event. NuVasive is also providing research funding for the Children’s Spine Study Group and the Growing Spine Study Group.

NuVasive was a key sponsor of EPOSNA 2017, the combined meeting of EPOS and POSNA, held earlier this month in Barcelona, Spain. In July, NuVasive is the leading sponsor of IMAST 2017, the International Meeting on Advanced Spine Techniques hosted by the Scoliosis Research Society. The Company is also the leading sponsor of ICEOS, the International Congress of Early-onset Scoliosis, in November.

The Company also announced the launch of a monthly podcast series, MAGEC Matters, featuring interviews with leading surgeons in pediatric deformity discussing tips for the treatment of early onset scoliosis, which is now available on iTunes, SoundCloud and other leading podcast platforms.

Other events supported by NuVasive throughout 2017 include:

  • Setting Scoliosis Straight: Patient & Family Power over Scoliosis Educational Event
    June 2-3, 2017; Miami
  • Shriners Hospital for Children – Chicago “Early Onset Scoliosis and Management Strategies” Meeting
    June 9, 2017; Chicago
  • International Meeting on Advanced Spine Techniques (IMAST)
    July 12-15, 2017; Cape Town, South Africa
  • Scoliosis Research Society (SRS)
    Sept. 6-9, 2017; Philadelphia
  • Pediatric Orthopedic Surgical Techniques Lab (POST)
    Sept. 29-30, 2017; Memphis, Tenn.
  • International Congress of Early-onset Scoliosis (ICEOS)
    Nov. 16-17; 2017, San Diego
  • 2017 MAGEC Users Meeting
    Nov. 17-18, 2017; San Diego
  • International Pediatric Orthopaedic Symposium (IPOS)
    Nov. 28-Dec 2, 2017; Orlando, Fla.
  • Spina Bifida Association Walk-n-Roll Events
    Various U.S. cities throughout 2017

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

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

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

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Forbes Names The DeAngelis Group Among the Top 250 Best Executive Recruiting Firms in 2017

Posted On May 19, 2017 By OrthoSpineNews In Recon, Spine /  

SCOTTSDALE, ARIZONA (PRWEB) MAY 19, 2017

The De Angelis Group, the largest search firm dedicated solely to the orthopedic industry was named amongst the top 250 “Best Executive Recruiting Firms” listed by Forbes for 2017. The recent article was published on http://www.forbes.com on May 3, 2017, written by Jeff Kauflin.

Forbes worked with analytics firm Statista to compile a list of 4,000 executive recruiting companies. They then asked thousands of recruiters, employees who have worked with recruiting companies and H.R. managers to take an online survey, and recommend up to 10 recruiting firms (excluding their own). With over 20,000 recommendations, each company was then ranked by the highest number of recommendations.

The De Angelis Group is proud to have been named on the 2017 Forbes list and looks forward to continually working hard to bring value to the orthopedic industry. The De Angelis Group’s Managing Partner, Drue De Angelis said after receiving the news “It is an honor to be recognized for this distinction but what truly compels us is helping drive enterprise value for the companies and investors who entrust us with their most critical executive hires.”
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About The De Angelis Group

Founded in 2000 with one thing in mind; driving enterprise value for Orthopedic Start-up companies. The DeAngelis Group works with many of the most innovative and exciting new companies in the early stages of development to build a Talented Leadership Team.Whether your company is new to the space or you require a turn-around, our consultants first gain a solid grasp of the deliverables and the specific experience that the leader will require and then conduct the search effectively and timely.  Our network in Orthopedics is vast and qualitative. We have developed algorithms to evaluate who best fits in the start-up environment and who can develop and execute a strategic plan achieving sustainable growth.

Visit The De Angelis Group’s website 

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FDA Clears Iovera Cold Treatment Device for Knee OA Pain

Posted On May 19, 2017 By OrthoSpineNews In Regulatory, Top Stories /  

Megan Brooks, Medscape – May 18, 2017

The US Food and Drug Administration (FDA) has cleared the iovera device, from Myoscience, Inc, for the relief of pain and symptoms associated with knee osteoarthritis (OA) for up to 90 days. Myoscience is located in Fremont, California.

“The iovera technology is a nonopioid and nonsystemic treatment for blocking pain signals from peripheral nerves,” the company said in a news release announcing FDA 51(k) clearance of the device.

The device uses the body’s natural response to cold to treat peripheral nerves. It consists of a hand piece equipped with a nitrous oxide cartridge and three closely spaced 27-gauge closed-end needle tips. The nitrous oxide flows from the cartridge to the needle tips, creating a highly localized cold zone. The effect is transient and provides pain relief until the nerve regenerates and its sensory function is restored.

“The iovera technology has the potential to change the current paradigm of pain management for osteoarthritis. The patients that I have treated with this technology have experienced immediate and long-lasting pain relief and are grateful to have an option that is nonnarcotic and nonsystemic,” Vinod Dasa, MD, member of the Myoscience medical advisory board, said in the release.

 

READ THE REST HERE

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