Orthopaedic Pediatric Market Draws New Companies, Products

Posted On June 1, 2017 By OrthoSpineNews In Extremities, Spine, Top Stories /

Carolyn LaWell – May 2017

EPOSNA 2017, the combined annual meeting of the European Paediatric Orthopaedic Society and Pediatric Orthopaedic Society of North America, served as an unveiling for new products, brands and companies as a focus on this niche market is drawing in device companies.

Two dozen device, bracing and pharmaceutical companies exhibited at EPOSNA in early May. The way Nick A. Deeter tells it, a decade ago there were three at the North American meeting: OrthoPediatrics (the company that Deeter founded in 2006), Biomet and Smith & Nephew. Attending EPOSNA with WishBone Medical, the pediatric company he founded earlier this year, Deeter said that he believes the pediatric segment is ripe for growth. For one, there is demand. WishBone estimates the market at $1.4 billion, growing at 10% per year. Two, it is one of the few areas in orthopaedics that has yet to gain attention from device companies—though our tracking of announcements in the space suggests that could be changing.

Here’s what’s happened just since 4Q16:

Implanet received global regulatory clearance for Jazz Frame connectors for use with the JAZZ Band in the treatment of adult and pediatric spinal deformity.
Materialise gained FDA clearance for Surgicase Orthopaedics to assist in pre-op planning for pediatric patients undergoing radius and ulna osteotomies.
Medicrea received FDA clearance of specialized posterior fixation and band connector components.
Mighty Oak Medical obtained FDA clearance for 3D-printed FIREFLY Pedicle Screw Navigation Guides, reported to be the only patient-specific pedicle screw guide indicated for use in pediatric patients.
NuVasive announced that it’s building up a salesforce for exclusive focus on pediatrics to promote its MAGEC rod for early onset scoliosis and PRECICE technology for limb lengthening.
Onkos Surgical, focused on the adult and pediatric surgical oncology market, received its first FDA 510(k) for the Eleos Limb Salvage System.
Orthofix launched JuniOrtho, a new brand to house services (apps, games, education tools) and products that treat pediatric orthopaedic and congenital deformities, including the TL HEX TrueLok Hexapod system and Guided Growth plates.
OrthoPediatrics, a solely-focused pediatric ortho company, launched a new distal femoral osteotomy system.
WishBone Medical formed and announced planned launch of single use, disposable implants and instruments for foot and ankle, trauma, spine and sports medicine indications.

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

Posted On June 1, 2017 By OrthoSpineNews In Spine /

By Andrew Nurre – May 22, 2017

SAN DIEGO, CA – May 22, 2017 – 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 industryleading 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.”

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Additive Manufacturing for Orthopedic Implants to Generate More Than $1B in Revenue Opportunities by 2026

Posted On June 1, 2017 By OrthoSpineNews In Financial /

CROZET, VA, May 31, 2017 /24-7PressRelease/ —

SmarTech Publishing, the leading provider of in-depth industry analysis services to the additive manufacturing industry, has published its first ever true industry opportunity deep dive market research report on the burgeoning ‘additive orthopedics’ industry, revealing an area of well-defined opportunity for additive manufacturing that is being faced with sizeable change over the next several years.

Additive manufacturing technologies have been employed by orthopedic device manufacturers for the production of approved medical implants for almost a decade, however the use of such technology is at a critical tipping point today. SmarTech’s proprietary market models have been adapted to this growing serial manufacturing opportunity as part of its ongoing analysis plan in biomedical 3D printing/additive manufacturing, and reveal that the additive orthopedic market generated nearly $500M in total opportunities in 2016.

Details of the report titled, “Additive Orthopedics: Markets for 3D-Printed Medical Implants – 2017” are available at
https://www.smartechpublishing.com/reports/additive-orthopedics-marke … lants-2017

About the Report:

Use of additive manufacturing (AM) technologies for the production of approved orthopedic devices has been a driving force in the growth of metal AM technology to address true serial manufacturing applications. Today, the industry is rapidly expanding these efforts to include not only titanium implants in new orthopedic care segments, but also the use of polymer and bioactive materials and 3D printing technologies to revolutionize the future of orthopedic care using implantable devices.

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CollPlant Provides Operational Update for Q1 2017

Posted On June 1, 2017 By OrthoSpineNews In Biologics, Top Stories /

NESS ZIONA, Israel, May 31, 2017 /PRNewswire/ —

CollPlant (TASE: CLPT), a regenerative medicine company utilizing its proprietary plant-based rhCollagen (recombinant human “rhCollagen”) technology for tissue repair products, provided an operational update for the first quarter ended March 31 2017.

During the period, the company continued to focus on product commercialization while pursuing its activities, including potential joint ventures with international companies, to develop biological ink (bioInk) for 3D printing of organs and tissues. Additionally, CollPlant has substantially reduced its operating costs, chiefly as a result of last year’s successful completion of clinical trials, and the transition to commercialization of its first products. Subsequent to the end of the first quarter, the company expanded its footprint in Europe with the signing of a distribution agreement in Turkey for its wound healing product, VergenixFG®, and is working towards the signing of additional distribution agreements in these territories.

The biological ink sector – Collagen protein is a fundamental and significant component of connective tissues in the human body, and is therefore an ideal building block for the synthesis of bioInk, which is used in the production of 3D scaffolds, together with human cells and/or therapeutic proteins. Management views this sector as a major growth opportunity and is, therefore, pleased to report during the period, that it has been actively pursing key collaborations with international companies in the field of 3D printing of organs and tissues utilizing CollPlant’s rhCollagen technology. Specifically, the Company is examining bioInk applications in the areas of orthopedics, dermatology, ophthalmology and cardiology, and others.

Yehiel Tal, Chief Executive Officer of CollPlant, stated, “CollPlant’s proprietary rhCollagen represents a potential key component of biological ink, due to a number of unique and important attributes, including its excellent biological functionality, which is reflected in its rapid cell proliferation. Our rhCollagen also has a high level of homogeneity at the molecular level, which enables the production of bioInk with controlled and supervised physical attributes such as viscosity, strength and transparency. Additionally, CollPlant’s rhCollagen has proven to be safe to use and does not cause allergic responses or lead to the transmission of diseases.”

According to the U.S. Department of Health and Human Services^[1], the number of people in the United States waiting for a transplant of a critical, life-saving organ such as a kidney, liver or pancreas, is approximately 118,000, and the organ transplant waiting list grows every year. BioInk is a significant component of the burgeoning 3D bioprinting market, which is expected to grow to approximately

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1. U.S. Department of Health & Human Services; https://optn.transplant.hrsa.gov/

USD 1.8 billion by 2022^[2], and to increase substantially as the printing technology, and all its components, continue to mature.

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

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2. Grand View Research; “3D Bioprinting Market Size To Be Worth $1.82 Billion By 2022,” April 2016

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: +1-917-322-2216
Email: pschwartz@rxir.com

SOURCE CollPlant

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Paxeon Reconstruction Appoints Kyle Sineath President and Announces His Role in Becker’s 15th Annual Conference

Posted On June 1, 2017 By OrthoSpineNews In Recon, Spine, Top Stories /

May 31, 2017

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces the promotion of Kyle Sineath to President. Prior to this appointment, Mr. Sineath served as Vice President of Global Sales for Paxeon. Mr. Sineath joined Paxeon after 10 years in the medical technology and orthopaedics industry, where he held a number of senior level leadership roles at Amedica and most recently, Vice President of Sales for NuTech Medical. Mr. Sineath holds a duel Bachelor of Science from the University of Pikeville.

“The orthopedics market has changed dramatically over the past 10 years and I am thrilled to be in a position to bring new products and creative ideas that further assist our surgeons deliver the best possible outcomes for patients around the world.” Said Mr. Sineath.

In addition to this appointment, Mr. Sineath has been asked to participate as a panelist at the upcoming Becker’s 15th Annual Spine, Orthopedic and Pain Management-Driven ASC Conference + The Future of Spine on June 22-24, 2017 in Chicago, IL.

With keynote speakers Andrew Hayek (Chief Executive Officer of Optum Health and Surgical Care Affiliates), Michael Kasper (Chief Executive Officer of DuPage Medical), Lou Dobbs (Fox News) and Marcus Allen (Former NFL Running Back and Member of the NFL Hall of Fame), this conference includes more than 1,100 Attendees at this World-class ASC Event Focused on Orthopedics, Spine and Pain.

In the session titled “Investing in Early Stage Spine and Device Companies – Smart? Dumb? and Practical Advice”, Mr. Sineath will be joined by President and CEO of AngelMD, Tobin Arthur, as well as President and CEO of Life Spine, Michael Butler. The session will be moderated by John Harig, JD.

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About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.

Month: June 2017