Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017

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November 28, 2018 OrthoSpineNews

Memphis, Tenn., (November 27, 2018) – In2Bones Global, Inc. today announces the commercial launch of the CoLink® View Plating System.

CoLink® View Bone Plates, marketed under the CoLink® View brand name, incorporate a unique combination of titanium metal and a high-performance polymer called polyether ether ketone (PEEK).

The CoLink® View Plates offer transverse joint compression through an X-ray transparent PEEK hub. This allows the surgeon to watch the patient’s bone fusion site during the post-surgical healing process.

Traditional metal plates cannot do this because metal absorbs X-rays and blocks the image underneath. The “see-through” hub is unique to this new In2Bones plating system, and one of many device innovations designed by the company.

In addition to X-ray transparency, PEEK has a benefit of being less stiff than metal and more similar to the elasticity of bone. Bones need mechanical stress (elasticity) during the healing process. Stiffer, all metal implants may eliminate the positive elasticity and slow healing.

The CoLink® View is the sixth In2Bones PEEK-related implant system to reach commercialization. It demonstrates In2Bones’ commitment to expanding the extremities market by launching innovative technological advancements to improve surgical outcomes and patient care.

For more information about In2Bones Global, Inc. extremity products, please visit www.In2Bones.com.

About In2Bones
Headquartered in Memphis, Tennessee, In2Bones is a global designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-usa.com.

Safe-Harbor Statement:
This press release contains “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. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.

Media Contacts:
Jon Simon | Sr. Vice President of Marketing
In2Bones USA
6000 Poplar Ave, Suite 115 Memphis, TN 38119
M: 512.739.5793 • O: 901.260.7931 • F: 844-712-6637
Email: jsimon@i2b-usa.com
https://www.linkedin.com/company/22344175/

Bob Reed
Element-R Partners
630.579.1770
bob@rurelevant.com

 


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November 27, 2018 OrthoSpineNews

WARSAW, Ind., Nov. 27, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today the U.S. launch of its new PediLoc® Femur Plate System. Building on the success of the existing PediLoc franchise, this upgraded offering boasts a lower profile screw to minimize soft tissue irritation, new locking drill guides, which simplify screw hole drilling and screw placement, and new 4.5mm straight locking compression plate options.

The breadth of this product offering allows surgeons to appropriately address multiple indications in patients with varying skeletal maturity levels by utilizing a plate that accurately fits the femur. Further, the enhanced system is configured for increased hospital and operating room synergy by utilizing OP’s existing core systems.

Joe Hauser, Vice President of Trauma & Deformity Correction, commented, “We are proud of our commitment to delivering innovative products to pediatric orthopedic surgeons. Our commitment to improve our legacy systems while also introducing new surgical systems demonstrates our dedication to providing superior surgical solutions for children. The PediLoc franchise is an important aspect of our business, and this enhanced system will provide our customers with new and improved implant options.”

About PediLoc Femur
The PediLoc Femur Locking Plate System is indicated for the treatment of pediatric femur fractures and osteotomies. The anatomic design of the stainless steel plates eliminates the need for intraoperative bending and contouring, while also providing superior fixation with either locking or non-locking screws.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

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


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November 19, 2018 OrthoSpineNews

SAN DANIELE DEL FRIULI, ItalyNovember 19, 2018 /PRNewswire/ —

LimaCorporate is pleased to announce that Michel Orsinger, Board Member of LimaCorporate’s Advisory Board, will assume the role of Chairman of the Board. Michel joined the Advisory Board mid-2017 following a long and successful global career in Orthopaedics.

Michel Orsinger held the position of Worldwide Chairman DePuy Synthes Companies at Johnson & Johnson (“J&J”) from 2012 to 2015, where he was also a member of J&J’s Global Management Team.  Michel joined J&J following the sale of Synthes Inc. for $20 billion in 2012.  Subsequently, Michel established the worldwide largest and most comprehensive orthopaedic company. Prior to his leadership role at J&J, Michel Orsinger was COO and CEO of Synthes Inc. for eight years and spent 11 years with Novartis.

Today, Michel is an investor as well as board member of several start-up companies, Chairman of a VC Fund and a senior advisor to EQT. He also joined the Board of the pharmaceutical company Takeda in 2016.

Valentin Chapero, who held the Chairman of the Board position from 2016, contributed to focusing the LimaCorporate strategic value proposition in terms of market approach, product portfolio and core technologies. He promoted operational excellence through the alignment of business processes as well as providing direction to expand LimaCorporate in M&A activities. Valentin also influenced the important country reorganizations rendering a customer-focused organization in many of LimaCorporate’s direct markets. Michel will now build on Valentin’s work making use of his global leadership experience, Orthopaedic expertise and extensive industry network.

Michel Orsinger will bring LimaCorporate to the next level as he has demonstrated in many other companies. He is a quality veteran of our industry with a strong track record of success which will enable him and the Advisory Board to support LimaCorporate’s development, including to push our digital agenda recently accelerated with the milestone-based acquisition of TechMah Medical LLC. I look forward to closely collaborating with Michel and I would like to personally thank Valentin for his dedication and leadership he brought to LimaCorporate”, said Luigi Ferrari, CEO of Lima Corporate.

About LimaCorporate 
LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

For additional information on the Company, please visit: limacorporate.com

SOURCE Limacorporate S.p.A.

(Logo: https://mma.prnewswire.com/media/637371/Lima_Corporate_Logo.jpg )


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November 14, 2018 OrthoSpineNews

NEW YORKNov. 13, 2018 /PRNewswire/ — Today, Press Ganey, a nationally recognized private company that measures patient experience, named Hospital for Special Surgery (HSS) a 2018 Press Ganey Guardian of Excellence Award® Winner. The Press Ganey Guardian of Excellence Award® was presented to HSS during their annual conference in Orlando, Florida.

“At HSS, we are committed to helping people move better so they can live better,” said Louis A. Shapiro, president and CEO at HSS. “As a world leader in musculoskeletal health, we put patients first and are honored to have earned this distinguished recognition for the sixth consecutive year.”

“We are proud to partner with HSS to support their mission to provide safe, high-quality, patient-centered care,” said Patrick T. Ryan, CEO of Press Ganey. “They are truly dedicated to delivering exceptional care in the communities they serve, and their commitment to capturing and acting on patient experience feedback is a very powerful demonstration of this.”

The Press Ganey Guardian of Excellence Award® is a nationally recognized achievement for those who have sustained performance in the top 5 percent for patient experience during the course of a year of data. HSS has been awarded this recognition for six consecutive years for outstanding inpatient and HCAHPS performance.

“It is rewarding to be part of a medical staff that is devoted to researching the latest advancements in treatment for all musculoskeletal conditions,” said Todd J. Albert, MD, surgeon-in-chief and medical director at HSS. “From motion analysis to virtual reality, HSS physicians implement the best practices in all initiatives to improve patient care and elevate patient satisfaction.”

“Getting patients back to how they want to live their lives is our utmost priority,” said Chao Wu, chief patient experience officer at HSS. “Guided by committed leadership, systematic feedback and a dedicated team of physicians and staff, we are able to continuously evolve our model of care to best treat each patient.”

About Press Ganey 
Press Ganey pioneered the health care performance improvement movement more than 30 years ago. Today, Press Ganey offers an integrated suite of solutions that enable enterprise transformation across the patient journey. Delivered through a cutting-edge digital platform built on a foundation of data security, Press Ganey solutions address safety, clinical excellence, patient experience and workforce engagement. The company works with more than 33,000 health care facilities in its mission to reduce patient suffering and enhance caregiver resilience to improve the overall safety, quality and experience of care.

About HSS | Hospital for Special Surgery
HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S.News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New JerseyConnecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic of musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery

Related Links

https://www.hss.edu


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November 13, 2018 OrthoSpineNews

SACRAMENTO, Calif.Nov. 13, 2018 /PRNewswire/ — Surgical Affiliates, a leading provider of in-house emergency surgical services for hospitals and healthcare systems, and Kern Medical of Bakersfield, Calif., a Level II Trauma Center, have announced their partnership to enhance patient care in providing 24/7 acute care and trauma surgical services.

Kern Medical’s partnership with Surgical Affiliates supports the hospital’s commitment to providing the highest quality of emergency surgical care as the only trauma center serving patients in California’s southern Central Valley. Through the partnership, Kern Medical’s excellent standard of care will be enhanced by ensuring patients have 24/7 access to the highest level of acute care and trauma surgical services supported by Surgical Affiliates’ proven expertise in emergency surgical care.


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November 6, 2018 OrthoSpineNews

KFAR SABA, IsraelNov. 6, 2018 /PRNewswire/ — CartiHeal, developer of Agili-C™, a proprietary implant for the treatment of joint surface lesions, announced today the publication of a study demonstrating that the Agili-C™ implant promotes the regenerative capacity of articular cartilage defects in human cadaveric ex-vivo model. The study, published in KSSTA Journal – Knee Surgery, Sports Traumatology, Arthroscopy (01 November 2018, PP 1-12), was conducted at Rush University in Chicago by Prof. Susan Chubinskaya.

The goal of the study was to investigate the ex-vivo Mechanism Of Action of the Agili-C™ implant in the repair of full-thickness cartilage defects. In particular, it was intended to validate whether the Agili-C™ implant has the potential to stimulate cartilage in-growth through chondrocyte migration into the 3D interconnected porous structure of the scaffold, along with maintaining their viability and phenotype and the deposition of hyaline cartilage matrix.

In the study, human articular cartilage cadaveric knee and ankle specimens were collected within 24 hours from death from 14 donors, male and female. To model a chondral defect, donut-shaped cartilage explants were prepared from each tissue specimen. Cartilage explants with or without the Agili-C™ implant inside were cultured for 60 days.

The results of the study confirmed the ability of chondrocytes to migrate outside of the cadaveric cartilage explant tissue and into the porous structure of the Agili-C™ scaffold and fill its entire volume with newly formed extracellular matrix (ECM) enriched in hyaline cartilage components, such as collagen type II and aggrecan, and lacking collagen type I.

In addition, the study demonstrated the formation of a layer populated by progenitor-like cells on the articular surface of the implant. These cells were able to produce a thin layer that covered the surface of the newly formed extracellular matrix, similar to a lamina.

In the absence of a scaffold, chondrocytes did not migrate far from the tissue with probably some degree of hypertrophy.

In conclusion, the analysis of samples taken from knee and ankle joints of human donors confirmed that the Agili-C™implant induces  deposition of new extracellular matrix with similar characteristics to the native hyaline cartilage inside the entire volume of the scaffold.

About CartiHeal

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C™ implant is not available for sale – it is an investigational device limited for use in the IDE study.

Contact                
info@cartiheal.com
www.cartiheal.com

SOURCE CartiHeal

Related Links

https://www.cartiheal.com/


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November 5, 2018 OrthoSpineNews

November 05, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of orthopedic medical imaging 2D / 3D, announces the change of its leadership effective January 1, 2019.

The Board of Directors, in agreement with Marie Meynadier, Chief Executive Officer of EOS imaging, has decided to change the leadership of the company to strengthen the company’s presence in the United States, its largest market, and expand its shareholder base.

The Board has unanimously appointed Mike Lobinsky, who joined the company in August 2017 as President North America, to the position of Chief Executive Officer effective January 1, 2019. Marie Meynadier will continue as Chief Executive Officer of EOS Imaging until December 31, 2018 and thereafter retains a position on the Board of Directors. Also being considered is Mike Lobinsky’s nomination to Director of EOS imaging at a subsequent Shareholder General Meeting.

Mike Lobinsky has over twenty years’ experience in the medtech industry with senior management roles in sales, marketing, operations and business development in the fields of Orthopedic Robotics, Navigation, Imaging and Implants. He has held leadership positions at Smith and Nephew, Brainlab, Blue Belt Technologies, Stryker and most recently contributed to the acquisition of Blue Belt by S&N prior to joining EOS in 2018.

Marie Meynadier, Chief Executive Officer of EOS Imaging, said, “I have enjoyed working with Mike for over a year. His leadership and knowledge of the industry, combined with his fine understanding of corporate culture, are excellent assets for EOS imaging and I have complete confidence in his ability to continue and accelerate the development of the company. Our North American market is considerable, and Mike will be able to develop it without denying our European roots, relying on the talented management team present in Paris, particularly Eric Maulavé, Chief Operating Officer, to continue to drive global growth. It was an honor and a great pleasure to serve the company and to develop it since its foundation. I am most grateful to the men and women within our staff, to our Directors, shareholders and clinical partners, who contributed to this development over these last years. Our teams can be proud of the work accomplished, and I have full confidence that they will continue to build our success under Mike’s leadership.

Gérard Hascoet, Chairman of the Board of Directors of EOS Imaging, commented: “Marie’s vision, her energy and her remarkable managerial talent have brought EOS imaging to a stage of excellence and a unique international reputation. Marie has given the company access today to an acceleration opportunity in the United States, which is a new step. She has managed to attract a management team capable of taking up this new challenge and ensure a successful succession. It is rare to be able to apprehend the future in such optimism.

Mike Lobinsky, President North America, EOS Imaging, added: “I am very grateful to Marie and the Board members for their trust and pleased to accept the CEO position. Few companies have accomplished what EOS has and these achievements have established a strong foundation for further development. The potential of our entire solution is outstanding, and I am confident in our ability to translate this into growth and value in the short, medium, and long terms.”

Valérie Worrall also joins the company as Chief Financial Officer. Valérie Worrall has more than twenty years of experience in leadership finance roles and as the CFO within business units in the healthcare industry. She has held positions in South East Asia, the United States, Switzerland, the UK, and France. She most recently was CFO of Balt, a medical device company.

ABOUT EOS IMAGING

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 33 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 280 installed EOS® platforms representing more than one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017.

For more information, please visit www.eos-imaging.com.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

Contacts

EOS imaging
Valérie Worrall, +33 (0)1 55 25 60 60
CFO
investors@eos-imaging.com
or
Investor Relations (US)
The Ruth Group
Matt Picciano / Emma Poalillo, 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com
or
Press Relations (US)
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com


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November 1, 2018 OrthoSpineNews

WARSAW, Ind., October 31, 2018 – Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced Ivan Tornos, previously Worldwide President for Urology/Medical and Critical Care at Becton, Dickinson and Company (NYSE: BDX), will join Zimmer Biomet as Group President, Orthopedics, effective November 1, 2018.

“Ivan is a great addition to our leadership team, bringing deep medical technology expertise and a strong history of successfully managing complex businesses across several continents,” said Bryan Hanson, President and CEO of Zimmer Biomet. “Ivan’s exceptional track record of executing on commercial strategies and driving growth and profitability will be critical to Zimmer Biomet as we continue our focus on achieving sustained performance in the business.”

Mr. Tornos comes to Zimmer Biomet having served for more than two decades in various global roles for Fortune 50 to 500 companies. In this newly created position, Mr. Tornos will be responsible for increased innovation, implementation and execution of the Orthopedics group, which will include our large joint, sports, extremities and trauma (S.E.T.) businesses as well as our Americas region.

About Ivan Tornos
Prior to joining Zimmer Biomet, Mr. Tornos served as Worldwide President of the Global Urology/Medical and Critical Care Division of Becton, Dickinson and Company.  Prior to that, he was with C.R. Bard, most recently serving as President, Europe, Middle East and Africa Regions. Before joining C.R. Bard, Mr. Tornos served as Vice President and General Manager of the Americas Pharmaceutical and Medical/Imaging Segments of Covidien International.  Before that, Mr. Tornos served as International Vice President, Business Development and Strategy with Baxter International Inc. and prior to that, he spent 11 years with Johnson & Johnson in positions of increasing responsibility.

Mr. Tornos is an alumnus of the Harvard Business School having graduated from the Advanced Management Program (AMP 187) and also completed Leadership and Management programs at the Cox School of Business of Southern Methodist University.  He finalized post-MBA work at the Wharton School of the University of Pennsylvania (CPD Marketing/Finance), holds an MBA from the University of Miami School of Business and a BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business.

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 orthopedic 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.

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 made. 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.

Contacts:

Media
Monica Kendrick
574-372-4989
monica.kendrick@zimmerbiomet.com

Investors
Coleman Lannum
574-371-9480
cole.lannum@zimmerbiomet.com

Derek Davis
574-372-4250
derek.davis@zimmerbiomet.com


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October 31, 2018 OrthoSpineNews

Parsippany, NJ – Oct 30, 2018

Extremity Medical, a global extremity implant company that provides innovative products for the upper and lower extremities, today announced the release of its newest implant system—the Omni Plating System. The Omni Plating System is designed to address a broad range of fusion procedures for the foot, and is integrated with the unique PlantarFiXTM Post. The PlantarFiX Post is a state-of-the-art technology that produces a broader surface area of compression across the joint to be fused. This compression advantage, along with the stability of the plate, eliminates the risk of plantar gapping seen in other dorsal plates and greatly assists in fusion, regardless of indication and patient bone quality.

“Now more than ever, Extremity Medical continues to expand our portfolio with innovative products that service the leading procedures for the foot and ankle surgeon,” said Matt Lyons, President of Extremity Medical. “Our philosophy is to create fusion technology based on the biomechanical principles of delivering consistent compression across the joint. That philosophy is behind the new PlantarFiX Post technology, which has been developed to integrate throughout the Omni plates.”

Lyons further explains “We are committed to delivering exciting new technology to meet the needs of the foot and ankle surgeon and to provide highly differentiated products. This portfolio expansion continues to demonstrate the Company’s strategic efforts to deliver the most differentiated portfolio in the extremity market.”

Extremity Medical, LLC is an orthopedic device company specializing in the development of next generation systems addressing unmet needs for the extremity surgeon. The Company, which is privately held, is based in Parsippany, NJ and markets its products in the U.S. via independent sales agents. For more information, please visit: http://www.extremitymedical.com


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October 25, 2018 OrthoSpineNews

KFAR SABA, Israel and MILANOct. 25, 2018 /PRNewswire/ — CartiHeal, developer of the proprietary Agili-C implant for the treatment of joint surface lesions, and the Principal Investigator Professor Elizaveta Kon, MD, PhD of Humanitas Orthopedic Center of Milan, announced today the successful enrollment and surgery  of  the 100th patient in the Agili-C IDE pivotal study.

“I’m excited to operate on the 100th patient in this important IDE study. The patient I enrolled and operated on today is a 47-year-old female, with a 3.6cm2 osteochondral defect in the center of the trochlea” said Prof. Kon. “The patient was randomized to the Agilli-C arm and treated with a single implant. I’m very pleased that the patient was randomized to the implant group, as I have very positive experience using this implant for similar indications. If everything goes as planned, I expect fast recovery and significant pain relief. This was my 8th patient in the study and I’m planning to enroll more patients shortly”, she added.

“I’ve been involved in CartiHeal’s previous clinical trials, and operated to date on over 40 patients with the Agili-C. Based on the positive clinical outcomes from the previous studies, I have strong confidence that this implant will be a game changer in the field of cartilage repair” concluded Prof. Kon.

Nir Altschuler, CartiHeal’s founder & CEO said: “Prof. Kon is a great surgeon and one of the first in the world to use our Agili-C implant. Her first patients were operated on over 4 years ago. We are pleased and impressed with her enrollment rate, and look forward to continuing our collaboration.

We’d like to thank all our Investigators and Study Coordinators for enrolling 100 patients in the first year of the study.”

The IDE study that was initiated a year ago is currently ongoing in the US, EU and Israel, with the purpose of an FDA PMA application. The trial’s objective is to demonstrate the superiority of the Agili-C implant over surgical standard of care (microfracture and debridement) for the treatment of cartilage or osteochondral defects, in both arthritic knees and knees without degenerative changes.

For more information about the study please refer to www.cartiheal.com

CartiHeal’s cell-free, off-the-shelf implant is CE marked for use in cartilage and osteochondral defects. Agili-C has been implanted in over 400 patients with cartilage lesions in the knee, ankle and great toe in a series of trials conducted at leading centers in Europe and Israel. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

About CartiHeal

CartiHeal, a privately-held medical device company with headquarters in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

In the United States, the Agili-C implant is not available for sale – it is an investigational device limited for use in the IDE study only.

Contact:           
info@cartiheal.com 
www.cartiheal.com

SOURCE CartiHeal

Related Links

http://www.cartiheal.com