Wednesday, December 30, 2015

News: Episurf Medical receives CE mark for its fourth product, the EpiGuide® MOS

EpiGuide® MOS is Episurf Medical's second “self certified CE-mark” product and the fourth patient specific application for the treatment of cartilage lesions of the Knee. With the addition of the EpiGuide® MOS, Episurf Medical expands its product portfolio to include a patient specific precision tool kit for the mosaicplasty procedure, a biological knee treatment aimed at people in the ages of 20 - 40 years which are considered too young for the Episealer® implant.

This information was published, 2015-12-21 15:58 CET (GLOBE NEWSWIRE) --  
Mosaicplasty is a treatment where cartilage from a healthy part of the joint is transferred to the area that has experienced damage. The procedure consists of transplanting cartilage and underlying bone from less weight bearing areas in the knee joint creating a mosaic pattern with the goal to fill the lesion completely with articular cartilage.

‘’Mosaicplasty is a difficult procedure that is very dependent on the skill of the surgeon. Pre-planning the procedure using MRI will help size estimation of the lesion and to plan for the optimal number and size of grafts needed, including mosaic pattern design. The EpiGuide® MOS aims to reduce the dependence of the skills of each surgeon, making it easier to perform a precise and fast mosaicplasty surgery, based on pre-planning and an individually unique guide”, says Rosemary Cunningham Thomas, CEO, Episurf Medical.

The EpiGuide® MOS can be designed to fit any mosaicplasty tools on the market, thus giving surgeons a viable and accessible guide kit that helps them improve accuracy and precision during mosaicplasty surgery.

“Episurf now has four patient specific products on the market which complement each other and allow us to meet the need for treating different types of knee joint lesions across differing age groups. We plan to market launch the EpiGuide® MOS in January 2016, giving our sales team in Europe an additional product within the Episurf range to offer clinics and surgeons”, Rosemary Cunningham Thomas continues.

In June 2015, Episurf Medical received the ISO 13485:2012 and Annex II certification which allows the company to CE-mark its own products. This enables Episurf Medical to have better control over its development projects and processes, which now can be shortened by 6-10 months, meaning that new products can reach the market faster. The EpiGuide® MOS is Episurf Medical’s second “self certified CE-mark" product.

About Episurf Medical

Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and personalized treatment alternatives. Episurf Medical’s Episealer® personalized implants and Epiguide® surgical drill guides are in development for treating localized cartilage injury in joints. Episurf Medical’s ╬╝iFidelity® system will enable implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention.

Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com. The information in this press release is such that Episurf Medical AB is required to disclose in accordance with the Securities Markets Act and/or the Financial Instruments Trading Act.


         For more information, please contact:
         Rosemary Cunningham Thomas, CEO, Episurf Medical
         Tel: +46 (0) 70-7655892
         Tel: +44 (0) 7803-753603
         E-mail: rosemary@episurf.com


Published at Nasdaq GlobeNewswire

News: Nextremity Solutions, Inc. Receives FDA 510(k) Approval for the Axi+Line Proximal Bunion Correction System

WARSAW, Ind., Dec. 22, 2015 (GLOBE NEWSWIRE) -- Nextremity Solutions, Inc., a surgeon-driven, pure-play foot and ankle orthopedic company located in Warsaw, Indiana, announced it has received 510(k) approval by the Food & Drug Administration to market its upcoming Axi+LineTM Proximal Bunion Correction System.

"The Axi+Line™ Proximal Bunion Correction System represents a significant advancement in the treatment of moderate to severe hallux valgus and is complementary to our Re+Line® Bunion Correction System. The Axi+Line™ system leverages the recognized benefits of the Mau osteotomy, while allowing our surgeons to have confidence in their operative technique. As with our other products, the final repair is very stable thanks to the innovative plating system, giving surgeons peace of mind and patients the potential to quickly get back to their daily activities," said Director of Product Development, Ryan Schlotterback.

Rod K. Mayer, President of Nextremity Solutions said, "We are very excited to receive 510(k) approval from the FDA for this new and innovative treatment option for patients. I'm extremely proud of our team and their efforts to produce yet another state-of-the-art device for the treatment of deformities in the forefoot. We look forward to taking the next steps to release this product into the hands of our surgeon consultants in our upcoming beta launch."

The Nextremity Solutions Axi+Line™ Proximal Bunion Correction System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot. An application for a CE mark is pending.

About Nextremity Solutions, Inc.
Nextremity Solutions, Inc. is a privately held medical device company offering innovative solutions and approaches to foot and ankle surgical intervention. The Company's procedure-ready, sterile implant systems for the correction of foot and ankle pathologies include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.

Dave Temple
Director of Marketing & Corporate Communications
Nextremity Solutions, Inc.
PH: 574-635-3022

Published at Nasdaq GlobeNewswire

News: Materialise Receives FDA NSE Letter for X-Ray 510(k) Submission

Image result for MATERIALISE NVLEUVEN, Belgium--()--Materialise NV (Nasdaq: MTLS), announced today that the company is in receipt of a not substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission for its innovative X-ray knee guide system. The system is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components, without MRI or CT.
Materialise NV offers health care professionals a full range of 3D surgical planning solutions, including personalized knee replacement solutions based on CT or MRI images, which are cleared by the FDA.
Wilfried Vancraen, Founder and CEO of Materialise states, “We are disappointed that the FDA concluded that, based on the information submitted, our X-ray knee guide system cannot be considered as substantially equivalent to our solutions based on CT or MRI images. While this decision will impact the timing of the marketing of our innovative solution in the United States, we will continue to pursue the regulatory clearance process, taking into account the feedback from the FDA.”
Cautionary Statement on Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements relating to, among other things, our planned commercialization efforts and regulatory approvals of our technologies as well as the success thereof and our research and development projects. These forward-looking statements are based upon the expectations of management under current assumptions at the time of this press release. We caution you that forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control that may cause our actual results to differ materially from our expectations. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise, unless we have obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.
About Materialise
With its headquarters in Leuven, Belgium, and branches worldwide, Materialise is a provider of Additive Manufacturing (AM) software solutions and sophisticated 3D printing services in a wide variety of industries, including healthcare, automotive, aerospace, art and design and consumer products. Materialise has been playing an active role in the field of AM since 1990, through its involvement in AM for industrial and medical applications, by providing biomedical and clinical solutions such as medical image processing and surgical simulations and by developing unique solutions for its customers' prototyping, production, and medical needs. For additional information, please visit: www.materialise.com.

Contacts

Press:
Materialise NV
Vanessa Palsenbarg, +32 16 39 66 37
Corporate Communications Specialist, Materialise
Fax: +32 16 39 66 00
or
Investors:
LHA
Harriet Fried/Jody Burfening, 212-838-3777

Published at BusinessWire

News: Extremity Medical Announces Initial Implantation for the KinematX Modular Hemi Wrist System

Image result for extremity medical
December 29, 2015 – Parsippany, NJ - Extremity Medical, LLC announces the first surgical implantation of the company’s KinematX Modular Hemi Wrist. The surgery was performed successfully by Gregory Packer, MD in Essex, United Kingdom and the patient’s immediate post-operative result was excellent. Mr. Packer commented,“Having just undertaken the first surgery using the modular KinematX implants, it was clear the modularity of this system offers a significant improvement over monolithic hemi-arthroplasty implants as it allows the implants to be matched to the patient’s specific anatomy much more closely and effectively.” 



The KinematX Modular Hemi Wrist represents the next generation for Extremity Medical’s KinematX platform. Building on the clinical success from the original monothilic implant design, the modular platform utilizes modular components in various sizes to match the patient’s individual anatomy and more closely mimic normal wrist motion. 

This first successful implantation marks the official entry of this next generation product into the European Market. Extremity Medical looks to expand its launch by releasing into several additional facilities in the European Union and Australia. Patient follow-up results from these procedures will be recorded by surgeons in an international wrist registry to determine patient outcomes with the new prosthesis. 

The initial investigators of the modular hemi device believe the improved motion will enable patients to resume sports and other activities that they enjoy. They also believe studies will show the implant to be more durable than traditional wrist replacements, which currently only last 5 to 10 years. 

Extremity Medical, LLC is an Orthopaedic device company specializing in the development of next generation systems addressing unmet needs for the extremity surgeon. The company currently has 10 products released globally which include specialized fixation and advanced arthroplasty systems for the lower and distal upper extremities. The company’s products are covered by an extensive portfolio of existing and pending patents.

News: AlloSource Granted Two Patents For Innovations In Cartilage Repair

AlloSource: Doing More with Life
CENTENNIAL, Colo., Dec. 29, 2015 /PRNewswire-USNewswire/ -- AlloSource®, one of the nation's largest providers of cartilage, cellular, bone, skin and soft-tissue allografts for use in surgical procedures and wound care to advance patient healing, received two patents from the United States Patent and Trademark Office for cartilage repair allografts.

The first, titled Perforated osteochondral allograft compositions, U.S. Patent Number 9,168,140, covers donated osteochondral tissue with a bone and cartilage layer perforated with small holes to allow for cellular migration and osteochondral repair. The second, titledMinced cartilage systems and methods, U.S. Patent Number 9,186,380, covers donated cartilage tissue processed to include small particles of cartilage containing living chondrocytes.
"The continued expansion of our intellectual property portfolio illustrates our dedication to growth and innovation," said Thomas Cycyota, AlloSource president and CEO. "AlloSource is passionate about developing new solutions for the medical community and will continue to be motivated by finding ways to honor the gift of human tissue donation by helping patients heal."
By focusing on quality, safety, service and a commitment to its mission, AlloSource has grown into one of the nation's largest tissue networks. The company's safety and tissue processing standards meet and exceed guidelines set forth by the United States Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB).
About AlloSource 
AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource's products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world's largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help heal severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country's most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766

Published at PRNewsWire

News: Anika Therapeutics, Inc. Announces First Patient Enrolled in FastTRACK Phase III HYALOFAST® Study

BEDFORD, Mass.--()--Anika Therapeutics, Inc., (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid technology, today announced the enrollment of the first patient in its pivotal HYALOFAST® FastTRACK Phase III clinical study.

“We have seen very positive clinical outcomes in the treatment of knees and ankles internationally using HYALOFAST. We believe the FastTRACK study will give us the pivotal clinical data to support a marketing application for an indication for the repair of cartilage defects of the knee in the U.S.”
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The HYALOFAST FastTRACK study is a prospective, randomized, active treatment-controlled, evaluator-blinded multicenter study to establish the superiority of a hyaluronan-based scaffold (HYALOFAST®) with autologous bone marrow aspirate concentrate (BMAC) in the treatment of articular knee cartilage defect lesions. The study will enroll approximately 200 patients at up to 30 sites in the U.S. and Europe.
HYALOFAST is a biodegradable scaffold that is used to enable cartilage regeneration in patients suffering from cartilage defects. European clinical data demonstrates that patients treated with HYALOFAST plus autologous BMAC in a one-step, minimally invasive arthroscopic procedure were able to successfully regenerate hyaline-like cartilage. HYALOFAST is CE Marked in Europe and is available commercially in 18 countries with more than 6,000 uses to date.
“HYALOFAST is an exciting, emerging product in our pipeline, representing Anika’s expansion into the rapidly evolving field of regenerative medicine in the orthopedics space,” said Dr. Charles H. Sherwood, President and Chief Executive Officer of Anika Therapeutics. “We have seen very positive clinical outcomes in the treatment of knees and ankles internationally using HYALOFAST. We believe the FastTRACK study will give us the pivotal clinical data to support a marketing application for an indication for the repair of cartilage defects of the knee in the U.S.”
“I congratulate the FastTRACK investigators for beginning enrollment in this trial,” said Dr. Alberto Gobbi, Global Principal Investigator. “We know from prior research that the HYALOFAST scaffold supports the adhesion, migration and proliferation of mesenchymal stem cells, and their differentiation into chondrocytes. We look forward to demonstrating the unique advantages of HYALOFAST in a randomized clinical trial.”
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedics medicines company based in Bedford, Mass. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions by providing clinically meaningful therapeutic pain management solutions along the continuum of care, from palliative care to regenerative medicine. The Company has over two decades of expertise developing, manufacturing and commercializing more than 20 products, in markets across the globe, based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio is comprised of marketed (ORTHOVISC® and MONOVISC®) and pipeline (CINGAL® and HYALOFAST® in the U.S.) products to alleviate pain and restore joint function by replenishing depleted HA and aiding cartilage repair and regeneration. For more information about Anika, please visithttp://www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the second, third, fourth, and fifth paragraphs 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 progress, size, and success of the clinical study of HYALOFAST and the clinical benefits associated with the use of HYALOFAST. 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 (i) the Company’s ability to successfully commence and/or complete clinical trials of its products, including for HYALOFAST or for expanded indications of the Company’s MONOVISC product, 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 or 510(k) 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 operate 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; (x) the Company’s ability to continue to successfully manage Anika Therapeutics S.r.l.’s business; and (xi) the Company’s ability to achieve its growth targets.

Contacts

Anika Therapeutics, Inc.
Christopher Ranjitkar, 781-457-9000
IR & Corporate Communications Manager

Published at BusinessWire

Monday, December 28, 2015

News: Newly Issued U.S. Patent for Knobbe Martens Client Pinnacle Spine Group, LLC

Knobbe Martens client Pinnacle Spine Group, LLC, a developer of innovative spinal fusion systems, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,216,096 titled Intervertebral Implants and Related Tools.  This patent is the third issued in the U.S. covering Pinnacle Spine’s innovative InFill® fusion technology.

The new patent is directed to systems that promote enhanced spinal fusion irrespective of implant type or approach.  This patent considerably strengthens the patent coverage provided by the Company’s previous patents relating to the Infill® Fusion technology and is part of the Company’s larger portfolio of U.S. and International filings.  The Company's prior patents relate to spinal implants and methods of post-filling to provide for superior fusion results.
"This new patent significantly broadens our overall intellectual property portfolio and, from a commercial standpoint, meaningfully strengthens our patent position in the area of spinal fusion," said Zach Sowell, President of Pinnacle Spine.  Mr. Sowell added that “Pinnacle Spine plans to continue to work with surgeons and partners to improve the Company’s systems and promote the promising technology behind the InFill® family of fusion systems. We believe that maximizing contact between graft and a well-prepared endplate is the best way to promote a robust fusion. The industry clearly agrees, as we are seeing more and more devices and systems adopting in-situ graft delivery. We are proud to be trend setters and look forward to a year of growth in 2016, with many exciting projects already underway.”
About Pinnacle Spine Group, LLC
Based in Dallas, Texas, Pinnacle Spine Group, LLC is a privately held medical device company that develops and markets innovative technologies to improve the safety and efficiency of many spinal fusion procedures.  The Company’s family of FDA-approved InFill® Fusion systems provides for superior results through the endplate to endplate contact of graft material achieved by post-filling implants after they have been delivered into targeted intervertebral spaces.
About Knobbe Martens
Consistently ranked among the top intellectual property firms in the nation and worldwide, Knobbe, Martens, Olson & Bear, LLP has over 300 lawyers and scientists nationwide and dedicates its practice to all aspects of intellectual property law, including litigation. Knobbe Martens serves a diverse group of clients from multinational corporations to emerging businesses of all stages. The firm is headquartered in Orange County, California, with offices in San Diego, Silicon Valley, Los Angeles, San Francisco, Seattle and Washington, D.C., and enjoys an international reputation for excellence. More information about the firm can be found atwww.knobbe.com.

News: Lima Corporate Continues Their Successful Path With a New Owner

SAN DANIELE DEL FRIULI, ItalyDecember 23, 2015 /PRNewswire/ --
Lima shares acquired by EQT
Lima Corporate LogoLima Corporate is pleased to announce that EQT has agreed to acquire the majority of the shares of the company. EQT's mission is to invest in market leading companies across the world with a mission to support sustainable growth through capital and industrial expertise.  The transaction is subject to regulatory approval in certain European jurisdictions.  Lima Corporate, since the entrance of the previous owner, Ardian, has been on a path of success, creating value that continues to grow.  The company in just a few years launched innovative products into the market in key segments, including implants for extremities and knee.  Lima Corporate has succeeded in acquiring key new business through the acquisition of ZUK unicompartmental knee, now re-branded Physica ZUKTM , and Discovery™ Total Elbow system for the European Economic Area, Switzerland and Japan as well as Vanguard™ for Denmarkand Sweden and the non-exclusive rights of the Vanguard™ technology for the European Economic Area.  Lima Corporate has also signed key partnerships to support their surgeons worldwide with auxiliary devices, such as patient-specific instruments and handheld navigation.
"We are pleased with the growth experienced by Lima during our ownership. Working alongside EQT, we are sure that Lima can continue its progress towards becoming a leader in the orthopaedic business," said Nicol├▓ Saidelli, Managing Director, Head of Ardian Italy.
Lima Corporate has been known as an innovative company, specializing in the production of titanium since the company was founded.  Today, Lima has become a reference player with a vertically integrated supply chain and the world's largest additive manufacturing outfit for the orthopedics medical device market.  
Having EQT as new majority shareholder will allow Lima Corporate to continue with its current strategy focused on exploiting its proprietary Trabecular Titanium technology for hip revision, strengthening its position in the knee market and providing one of the most complete and innovative portfolios for the extremities characterized by a long-standing clinical history for the shoulder replacement.
"I have to thank all the people that have believed in Lima Corporate, from our board to our shareholders to our surgeons and our employees.  By working together, we are confident to continue to provide surgeons and their patients the most effective and safest implant technology on the market today," said Luigi Ferrari, CEO of Lima Corporate.  
"EQT has followed Lima for almost ten years and we are impressed by the Company's growth history as well as the strength of the management team. We are now keen to support Lima in its next phase of development. Lima is well-positioned for future growth and we are convinced it can be accelerated by leveraging our industrial network and resources. We look forward to working with the management team to achieve the full potential of Lima," says Michael Bauer, Partner at EQT Partners AG, Investment Advisor to EQT.
A key success factor of Lima Corporate is thanks to the over 750 employees worldwide.  The company, just in the last three years, added over 30% more employees and opened a number of new subsidiaries, some of the most recent being South KoreaTurkey,DenmarkBelgium and South Africa.  "Our employees are the most important asset of Lima.  The passion with which they do their jobs and their attention to detail are the strongest I have seen in the industry," Mr. Ferrari added.
About Lima Corporate  
Lima Corporate is a global medical device company providing reconstructive orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, Lima Corporate is committed to the development of innovative products and procedures to enable surgeons to select the ideal solution for every individual patient. Lima Corporate's product range includes large joint revision and primary implants and complete extremities solutions including fixation.
For additional information on the Company, please visit http://www.limacorporate.com
About EQT  
EQT is a leading global private equity group with approximately EUR 29 billion in raised capital. EQT has portfolio companies inEuropeAsia and the US with total sales of more than EUR 17 billion and 140,000 employees. EQT works with portfolio companies to achieve sustainable growth, operational excellence and market leadership.
For further information, please visit http://www.eqt.se
About Ardian  
Ardian, founded in 1996 and led by Dominique Senequier, is an independent private investment company with assets of US$50bnmanaged or advised in EuropeNorth America and Asia. The company, which is majority-owned by its employees, keeps entrepreneurship at its heart and delivers investment performance to its global investors while fueling growth in economies across the world. Ardian's investment process embodies three values: excellence, loyalty and entrepreneurship.
Ardian maintains a truly global network, with more than 410 employees working through twelve offices in ParisLondonFrankfurt,MilanMadridZurichNew YorkSan FranciscoBeijingSingapore, Jersey and Luxembourg. The company offers its 433 investors a diversified choice of funds covering the full range of asset classes through Ardian Funds of Funds (comprising primary, early secondary and secondary activities), Ardian Private Debt, Ardian Direct Funds (comprising Ardian Mid Cap Buyout, Ardian Expansion, Ardian Growth and Ardian Co-Investment), Ardian Infrastructure, Ardian Real Estate and customized mandate solutions with Ardian Mandates. http://www.ardian.com
Limacorporate spa
Via Nazionale, 52
33038 Villanova di San Daniele
Udine - Italy