Anika Announces Regulatory Approval for MONOVISC® in India

July 24, 2017

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 that regulatory authorities in India granted approval to MONOVISC®, its single injection viscosupplement for the treatment of pain associated with osteoarthritis of all human synovial joints. MONOVISC is commercially available in the United States, Canada and Europe, and Anika plans to expand into India, Australia, New Zealand and additional international markets over the next six to nine months.

Expanding our global commercial footprint is one of our key strategic pillars of growth, and the approval of MONOVISC in India is a proof point for our ability to execute against the benchmarks we define each year,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer of Anika Therapeutics. “There is a growing demand for non-invasive, long-acting treatments for osteoarthritis in emerging countries such as India where knee replacement surgery is often the last option or not an option at all, due to limited medical resources outside major cities and high costs of surgery and postsurgical care.With its ability to safely relieve pain for up to six months with fewer office visits, lower treatment costs and no downtime after treatment, MONOVISC is poised to be well-received by physicians and patients in India.”

The global expansion of MONOVISC is the primary international orthobiologics revenue driver for Anika, and India represents a large and growing market opportunity. Anika has a multi-year, exclusive distribution agreement with Modi-Mundipharma Pvt. Ltd. (“MMP”) to market MONOVISC in India. MMP is a leading multinational pharmaceutical company with a significant focus on pain management. Utilizing their large, dedicated sales force, MMP will be able to introduce MONOVISC to a broad range of physicians that treat a substantial number of patients suffering from the symptoms of osteoarthritis.

About MONOVISC

MONOVISC is Anika’s next-generation HA-based therapy for treating osteoarthritis that features enhanced durability in a safe, easy-to-use, single injection regimen. MONOVISC is made from highly purified, non-animal, natural hyaluronan. Hyaluronan occurs naturally throughout the body, especially in articular cartilage, synovial fluid in joints and in the skin. For more information about MONOVISC, please visit Anika’s website at www.anikatherapeutics.com.

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 second sentence of the first paragraph, second sentence of the second paragraph, and first sentence of the third paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s international expansion plans, the market for the Company’s products in emerging countries such as India, and the Company’s Monovisc Product as a revenue driver for the Company. 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
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

Xtant Medical to Announce Second Quarter 2017 Results on August 9th, 2017

BELGRADE, Mont., July 24, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that it will release its financial results for the second quarter ended June 30, 2017, after the close of the financial markets on Wednesday, August 9, 2017.

An accompanying conference call will be conducted by Carl O’Connell, Chief Executive Officer and President, and John Gandolfo, Chief Financial Officer, to review the results. The call will be held at 10:00 AM ET, on Thursday, August 10, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Details
Conference Date: Thursday, August 10, 2017 10:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Xtant Medical Holdings, Inc. Second Quarter 2017 Results Call
Webcast Registration: Click Here
Following the live call, a replay will be available on the Company’s website, www.xtantmedical.com, under “Investor Info”.

About Xtant Medical
Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements
This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

OBERD powers Regenerative Orthobiologics Registry to advance orthopaedics

COLUMBIA, Mo.July 24, 2017 /PRNewswire/ — Columbia, Missouri-based Universal Research Solutions (a.k.a. OBERD) has joined the Regenerative SportsCare InstituteOrthohealing Center and the University of California: Davis to create the Regenerative Orthobiologics Registry (ROR) powered by OBERD.  ROR is the official registry of The Orthobiologic Institute (TOBI), and leverages OBERD’s healthcare data registry platform to advance evidence-based care to standardize regenerative orthobiologics procedures.

ROR’s commitment to empowering healthcare organizations to enhance the patient experience and benchmark performance aligns with OBERD’s expertise in musculoskeletal outcomes data collection. OBERD’s registries provide large data sets for benchmarking, research, and quality improvement initiatives. Its family of musculoskeletal registries has been established based on procedure, under specific platforms including: hip and knee; hand and wrist; foot and ankle; spine; and sports medicine.

“The Regenerative Orthobiologics Registry was created as a united initiative to improve data collection in the field of Orthobiologics,” said Kwadwo Boachie-Adjei, ROR’s Chief Technology Officer. “ROR offers valuable opportunities to learn, connect and contribute, and is designed to help practitioners and researchers navigate the changing landscape of orthobiologics in regenerative medicine by providing access to high quality data sets for benchmarking, research, and quality improvement.”

ROR seeks to become the international registry for regenerative orthobiologics, beginning with capturing 90% of all regenerative medicine procedures in the U.S. within the next 5 years, and to leverage this comprehensive data to:

  • Enhance orthobiologic quality of care
  • Improve patient outcomes and safety
  • Manage and reduce costs
  • Advance orthobiologic science and bioengineering

“OBERD is delighted to support this initiative and provide the tools to collect essential data in this exciting medical field,” said Andrew Clement, Chief Commercial Officer. “The Registry will enable users to easily contribute to a national database that, through the use of OBERD’s infinite range of filter combinations, can provide the raw data for innovative research in the future.”

About Regenerative Orthobiologics Registry
The Regenerative Orthobiologics Registry (ROR) is a stand-alone non-profit (501c3) founded in 2017 by Dr. Gregory Lutz, Dr. Steven Sampson, Dr. Hunter Vincent, and Dr. Christopher Lutz. A multi-stakeholder, independent organization with diverse national and international constituents led by top Physiatrists and Interventionalists, ROR aims to connect the orthobiologics community with this international data registry.
Learn more at www.roregistry.org

About Universal Research Solutions (OBERD)
Universal Research Solutions (a.k.a. OBERD) owns, develops, implements and supports the OBERD (Outcomes Based Electronic Research Database) system. OBERD optimizes the data collection necessary to empower evidence-based medical practice, improve the quality and efficacy of care and advance clinical decision-making and patient understanding. OBERD has been collecting patient outcomes data in orthopaedics for over 7 years, with over 10 million scored forms from over 2 million patients in its database. It includes a QCDR, with CMS-approved measures specific to orthopaedics. For more information, visit www.oberd.com or follow the company on Twitter @oberdnews.

 

SOURCE OBERD

Related Links

http://www.oberd.com

Despite federal delays, bundled payments will be entrenched in US healthcare

AUTHOR Les Masterson/July 17, 2017

Amid yet another delay in CMS-led bundled payment programs, the popular value-based reimbursement model seems poised to continue as a favorite for providers. Bundled payments serve as an entry to value-based care because of the relatively low risk providers take on. And while these programs aren’t yet proven to be successful, there is enough positive data to excite those who champion paying for healthcare based on value.

Bundled payment models have been around for decades, but they really started to grow as President Barack Obama took office and the CMS started to role out demonstration projects and other initiatives. Although CMS under the current administration is less enthused for bundled payments, the industry trend isn’t likely to stop.

Private payers are getting in the game, too, so hospitals should invest in EHRs that allow real-time care coordination, and should consider trying voluntary programs as an on ramp to the process.

More delays

CMS in recent months has delayed starting and expanding bundled payment programs that would further move payments from fee-for-service (FFS) to a value-based system. The delays have caused concerns in the industry, but CMS said they allow for additional review and feedback from the industry.

The federal agency has also delayed the start of some programs to next year as well as put a pause on expanding others. These weren’t CMS’ first bundled payment program delays.

The American Hospital Association supported the delay in April, but spoke out against additional delays and potential burdens on providers. “As it exists, the rule places too much risk on providers with little opportunity for reward in the form of shared savings, especially in light of the significant upfront investments required,” said AHA Executive Vice President Tom Nickels.

Recent delays are particularly concerning because HHS Secretary Dr. Tom Price has been a vocal critic of mandatory bundled payment programs. Still, Price supports voluntary programs and backed the bipartisan Medicare Access and CHIP Reauthorization ACT (MACRA) when he was in Congress.

 

READ THE REST HERE

Paragon 28® expands innovative product portfolio with the launch of the PROMO™ Triplanar Hallux Valgus Correction System

ENGLEWOOD, Colo.July 21, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28® has launched innovative products and instrumentation that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

PROMO or Proximal Rotational Metatarsal Osteotomy is a hallux valgus correction system designed to allow complete bunion correction in multiple planes. Recent studies have shown that up to 87% of hallux valgus (bunion) deformities contain a frontal plane rotational deformity.1  While traditional single-plane procedures such as the scarf or chevron osteotomes only correct the transverse deformity, PROMO simultaneously corrects the metatarsal internal pronation as well as the varus deformity through a single, oblique osteotomy.

The patent-pending PROMO System contains a series of custom jigs and implants utilized in the measurement, construction and fixation of an oblique plane osteotomy specific to the patient’s deformity. Unique plates are included that are sized and shaped around the oblique angulation of the osteotomy. PROMO also includes a PRECISION™ guided system which enables the user to place a cross screw across the osteotomy while avoiding hardware collision with the plating construct.

Features & Benefits:

  • Corrects all deformity parameters including rotation in the frontal plane
    • May help decrease chance of recurrence2
  • Single Oblique Osteotomy
    • Reduces the likelihood of shortening which can help prevent transfer metatarsalgia
    • Osteotomy allows for placement of an interfragmentary screw which increases the rigidity of the construct
  • Custom jigs aid in construction of the oblique plane osteotomy
    • Repeatable and streamlined technique
  • Avoids fusing the first TMT joint
    • Helps sustain patient joint health

Paragon 28 is grateful for the significant contributions Dr. Emilio Wagner, MD, and Dr. Pablo Wagner, MD, made as surgeon designers of this system.

For additional information on the PROMO™ Triplanar Correction System, visit the Paragon 28 website at www.Paragon28.com.

1  Kim Y, Kim JS, Young KW, et al. A new measure of tibial sesamoid position in hallux valgus
in relation to the coronal rotation of the first metatarsal in CT scans. Foot Ankle Int. 2015; 36(8): 944-52.

2  Wagner P, Wagner E, Ortiz C. Rotational osteotomy for hallux valgus.
A new technique for primary and revision cases. Tech Foot Ankle Surg. 2017; 16(1): 3-10

Contact: Jim Edson, Director of Product Management and Marketing, jedson@paragon28.com

 

SOURCE Paragon 28

Related Links

http://www.Paragon28.com

Tissue Regenix Announces Proposed Acquisition of CellRight Technologies

July 21, 2017

SAN ANTONIO–(BUSINESS WIRE)–Tissue Regenix, the UK-based regenerative medical devices company, today announced the proposed acquisition of CellRight Technologies, a U.S. regenerative medicine company based in San Antonio, TX. This acquisition would bring together two highly complementary technology and product platforms focused on soft-tissue regeneration and regenerative bone matrices, respectively.

The deal accelerates both companies’ vision to becoming a global leader in regenerative medicine by accelerating growth and penetration into key U.S. markets. The combined group will have a highly complementary product offering with CellRight Technologies’ existing orthopedic portfolio, based on human-derived bone graft products, and Tissue Regenix’s soft tissue products based on its patented decellularisation dCELL® Technology (dCELL®), a multi-tissue regenerative medical platform.

The combined group provides CellRight Technologies with the infrastructure of a larger, multi-national organization and a platform to enter new geographies. CellRight Technologies’ human tissue-based products, including Matrix OI, will expand the current Tissue Regenix portfolio, which includes DermaPure® for wound care applications. Additionally, CellRight Technologies’ existing tissue bank in San Antonio, TX, provides Tissue Regenix with a purpose built U.S. base to self-manufacture products utilizing its patented dCELL® process.

Combined with the capabilities of CellRight Technologies’ osteobiologics, this acquisition positions Tissue Regenix to launch into the U.S. orthopedics market in early 2018 with a focus on ligament reconstruction, initially addressing anterior cruciate ligament repair, through OrthoPure® HT, a decellularised human tendon.

“We are excited by the huge potential that this acquisition brings for the advancement of regenerative medicine to our patients globally,” said Antony Odell, CEO of Tissue Regenix. “We are combining two highly complementary companies that are committed to developing a robust portfolio of products and we are poised for rapid growth through our existing product offering with plans for multiple U.S. launches over the next two years.”

CellRight Technologies has seen tremendous success in the U.S., including leveraging strong relationships with orthopedics and sports medicine companies. Founder and CEO Jesus Hernandez has been at the heart of research and development for the CellRight Technologies product line.

“Becoming part of the Tissue Regenix family is an exciting and important milestone for our company,” said Jesus Hernandez, founder and CEO of CellRight Technologies. “With the combined talent and expertise in biologics, we look forward to continuing to lead regenerative medicine, bringing our patients and healthcare partners the products and innovation which enhance their lives. We are all excited at the potential of what we will be able to accomplish together.”

For more information about Tissue Regenix, please visit http://www.tissueregenix.com/.

Important notice

The information contained herein is not for release, directly or indirectly, in or into Australia, Canada, Japan or the Republic of South Africa. This document (and the information contained herein) does not contain or constitute an offer of securities for sale, or solicitation of an offer to purchase securities, in the United States, Australia, Canada, Japan or the Republic of South Africa or any other jurisdiction where such an offer or solicitation would be unlawful. The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States unless the securities are registered under the Securities Act, or pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. No public offering of the securities will be made in the United States.

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company’s patented decellularisation (‘dCELL®’) Technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient’s body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

About CellRight Technologies

CellRight Technologies is the industry leader of osteoinductive matrices and is committed to providing clinicians and their patients with verified osteoinductive implants known to positively impact patient and fusion outcomes. In-vivo and in-vitro testing to verify osteoinductivity is performed post-sterilization by an independent testing laboratory using validated osteoinductivity test methods.

Contacts

Racepoint Global
Jeff Stoecker, +1-617-624-3424
jstoecker@racepointglobal.com

Singapore launches $13M 3D printing center with focus on medical research

Jul 21, 2017 | By Tess

A new 3D printing center with a focus on healthcare research was inaugurated in Singapore this morning. Called the National University of Singapore Centre for Additive Manufacturing (AM.NUS), the new facility is initially being funded by a grant of S$18 million (around $13,208,102) provided by NUS, the National Additive Manufacturing Innovation Cluster (NAMIC), and the Singapore Economic Development Board (EDB).

Researchers at AM.NUS, which was launched earlier today by Mr. Amrin Amin, a Parliamentary Secretary at the Ministry of Home Affairs and Ministry of Health, will reportedly work alongside the NUS’ Yong Loo Lin School of Medicine, as well as its Faculties of Engineering, Science, and Dentistry, and its School of Design and Environment.

The goal of establishing the new additive manufacturing center is to advance 3D printing technologies in the fields of biomedicine and healthcare and to “boost” NUS’ standing in the field of biomedical additive manufacturing.

“The NUS Centre for Additive Manufacturing will play a critical role in supporting Singapore’s vision of becoming a leading AM hub,” commented Professor Jerry Fuh Ying-Hsi, Co-Director of AM.NUS and the Thrust Lead of Restorative Repair & Implants from the Department of Mechanical Engineering at the NUS Faculty of Engineering.

“Through this inter-faculty pooling of expertise, we hope to boost technology capabilities as well as advance intellectual property development and commercialization of AM-enabled biomedical technologies.”

The new AM center will focus its research on a number of specific areas, including the development of customized 3D printed surgical instruments, simulators, and functional prosthetics; 3D printing-enabled customized medicine (i.e. personalized drug formulations, dosages, and drug release); advancing tissue repair using 3D printed scaffolds and tissue engineering; developing restorative repairs and implants with ceramic and metal 3D printing; and oral health and craniofacial applicaitons, which will be conducted with the NUS Faculty of Dentistry.

 

READ THE REST HERE

Medtronic Announces Infuse Settlements

Walter Eisner • Thu, July 20th, 2017

Medtronic plc says it has reached an agreement with “substantially all” remaining claimants involving the Infuse bone graft product.

In a June 27, 2017 10K filing with the SEC, the company announced the agreements with approximately 6,000 claimants. The company also said it has set aside $300 million for “certain litigation charges” in the filing.

The company had previously disclosed reaching settlements in more than 4,000 Infuse patient lawsuits. In December 2016, a judge in St. Louis cleared the way for the first jury trial involving personal injuries allegedly caused by Infuse. That trial could have opened sealed internal documents that could have been used in other trials.

According to the Minneapolis Star Tribune, the company paid at least $85 million in a settlement to shareholders in 2012 to resolve allegations that it failed to reveal that most sales of Infuse were for off-label surgeries. In 2014, Medtronic said it paid $22 million to 950 injured Infuse patients. The company denied wrongdoing in each settlement.

Remaining Investigations

While the announcement settles private claims, the company is still under investigation by various state attorneys general who have issued subpoenas or document requests in Massachusetts, California, Oregon, Illinois, and Washington seeking more information regarding the Infuse device.

 

READ THE REST HERE

 

Invibio and Carbofix Partnering With UK Olympic Sprinter James Ellington on New “Passion For Progress” Initiative

THORNTON CLEVELEYS, EnglandJuly 13, 2017 /PRNewswire/ —

UK Olympic sprinter James Ellington has joined forces with the UK´s Invibio Biomaterial Solutions and CarboFix Orthopedics on his road to recovery and his overall ambition to return to the world stage of athletic competition after a devastating motorcycle accident in Tenerife earlier this year.

(Photo: http://mma.prnewswire.com/media/535235/Invibio_Biomaterial_Solutions.jpg )

The two companies and the athlete share a passion for progress and pushing boundaries; for James Ellington, mentally and physically first in sport and now in recovery, and for CarboFix and Invibio with innovative biomaterials and devices that have the potential to change the treatment of trauma fractures. For patients recovering from traumatic injuries this could serve as an inspiration not to lose track of their goals and passion.

Changes in destiny couldn´t be more pronounced for an athlete like James Ellington, who suddenly turned from being a world-class, elite sprinter training for his next competition to a patient in recovery facing an unknown future. However, even the life-changing experience of a severe head-on collision of his motorbike with a car hasn’t stopped James Ellington from fighting for his goals, despite having his legs and pelvis completely smashed.

“In extreme situations, it’s important not to lose faith and to consider all (therapeutic) options available,” explains Ellington. “I had a severe tibia fracture, and was offered two choices to fix it: a traditional Titanium nail or a Carbofix nail using a relatively new, but promising carbon fibre, composite technology. For me, it’s all about giving myself the best chance of achieving my goal and returning to competitive athletics. I chose the Carbofix nail because it’s lighter weight and for its faster healing potential.” Continues Ellington, “The rod is made from a new composite polymer. It’s strong, in a way that’s similar to metal implants, but not as stiff, which means it has the capability to stress the bone more and provide some micro-motion, so it works more like natural bone. The idea is that this will help support a quicker recovery – which is what convinced me this was the right path for me.” The sprinter nevertheless considers himself lucky: because he survived, is not paralyzed, is walking again and is so far on a good recovery path that may also include running in the future.

With trauma implants made from Invibio’s PEEK-OPTIMA™ Ultra-Reinforced, a composite polymer, CarboFix Orthopedics is hoping to support James and other patients in a similar position. Ron Szekely, the company´s Vice President of Sales and Marketing, says: “The aim itself to get back on track is fantastic, whether that’s the athletic track or returning to other individual recovery goals. This can be an important driver for rehabilitation. In addition to dedication and enthusiasm, patients need to have access to innovative medical devices that can support this. At CarboFix we believe in the potential of changing trauma treatment to improve the quality of life for many patients.”

Coming back (on track): high quality of life is an important aspect for recovery

“James Ellington´s passion for progress is the common denominator and connecting link between himself and Invibio,” explains Medical Business Unit Director, John Devine of Invibio Biomaterial Solutions. “Metals have been used to treat trauma fractures for decades, but patient demands for a quicker recovery with fewer device breakages coupled with the global increase in patient risk factors such as obesity and diabetes mean we need to be open to progress. That includes being open to the possibility that new innovative carbon fibre reinforced devices made from less stiff materials could really change how successful surgery and patient recovery is. The medical (device) industry itself very often and for good reasons, has to make small albeit important steps, to overcome challenges and achieve substantial progress towards the ultimate objective of improving patient outcomes and quality of life. James knows exactly how that feels and his positive attitude and firm belief in capabilities and future performance is another point we have in common.”

Inspiring people to achieve new records

This “passion for progress” after a traumatic injury or challenging operation is a theme supported by the two companies and centering on James Ellington´s hope to become an active athlete again. Together, Ellington, CarboFix and Invibio are pleased that James has already achieved so much in the months since the accident. The progress and hope shown by James Ellington could also help and inspire patients and trauma surgeons alike – whether Ellington is a pioneer by being an Olympic athlete sprinter again, or simply back and participating in the race of life.

About CarboFix

CarboFix Orthopedics, is the world-wide leader in developing, manufacturing and marketing orthopedic implants made of continuous Carbon-Fiber reinforced polymers.

The products company currently markets around the world its Piccolo Trauma and Carboclear spine lines.

CarboFix is working worldwide through its distributor network and through its subsidiaries in the US, China and Israel.
https://www.carbo-fix.com/

About Invibio Biomaterial Solutions
Invibio, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers.  The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in around nine million implanted devices worldwide.

INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies.  All rights reserved.

About Victrex plc

Victrex, headquartered in the UK, is an innovative world leader in high performance polymer solutions focused on the Aerospace, Automotive, Electronics, Energy and Medical markets. Every day, millions of people rely on products or applications which contain our polymers, from smartphones, aeroplanes and cars to oil & gas operations and medical devices. With over 35 years’ experience, we are delivering leading edge solutions to shape future performance for our customers and our markets, and to drive value for our shareholders. Find out more at http://www.victrexplc.com

Copyright ©2017 Invibio Ltd.

SOURCE Invibio Biomaterial Solutions

Smith & Nephew joins forces with Imperial’s Biomechanics Group

19 July 2017/by Naomi Black

The medical device giant Smith & Nephew have signed a 3-year partnership with a research group in the Department of Mechanical Engineering to find new ways to support one of our most important joints.

With an increasing participation in sport, and a trend to keep active later in life, the treatment of sports injuries of the knee has been identified by Smith & Nephew as one offering high growth opportunities.

The USD $1m research study is led by Professor Andrew Amis, Professor of Orthopaedic Biomechanics and leader of The Biomechanics Group, who already has a long-standing working relationship with the company.  His expertise with artificial ligaments and total and partial knee prostheses as well as field experience working directly with surgeons has set the groundwork for this latest agreement.

 

READ THE REST HERE