June 28, 2018
ContactsCatalyst OrthoScience Inc. Brian K. Hutchison firstname.lastname@example.org or Surgence Communications Strategies Wendy Crites Wacker, APR, 352-494-2129 email@example.com
JUN 28, 2018 Episurf Medical (NASDAQ: EPIS B) today announces that the company has reached an important milestone on its strategy to reach the US market. The Investigational Device Exemption (IDE) application that the company has been working on is ready for filing. The application will now be filed to the US Food and Drug Administration (FDA) prior to the end of the second quarter. An approved IDE allows a medical device to be used in a clinical study in order to collect safety and effectiveness data for submission to the FDA. Episurf Medical is filing the IDE application for the Episealer® knee implant to get approval to initiate a clinical study in the US. The IDE must be approved by the FDA before the study is initiated. “Episurf has performed thorough work to get the extensive submission package in place. The Episealer® technology is gaining a lot of interest among the potential study investigators and we are continuing the work of getting sites ready for participation” comments Dr. Mike Kelly, Special US Study Advisor to Episurf Medical. “We are looking forward to getting feedback on the study design from the FDA and continue the constructive dialogue we have had with the FDA in the preparatory phase. We are eager to take the next steps towards the US market and this is a very important milestone in that respect. I think the pieces are falling in place for us. Simultaneously as we are executing on a very clear regulatory strategy in the US, we have a growing business in Europe, where we also have a high level of activity when it comes to clinical activities. Our strategy is very clear, the clinical results are very strong, and this is such an important step. Finally, I am very proud of the team that delivered this in time, it’s been a lot of hard work behind this” comments Pål Ryfors, CEO, Episurf Medical. For more information, please contact: Pål Ryfors, CEO, Episurf Medical Tel:+46 (0) 709 62 36 69 Email: firstname.lastname@example.org 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 personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized cartilage injury in joints. Episurf Medical’s μiFidelity® system enables 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. This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CEST on 28 June 2018.Read More
Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology™ Hyperlordotic ALIF Interbody Spinal Fusion System
REDLANDS, Calif. and AUSTIN, Texas, June 28, 2018 /PRNewswire/ -- Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® SA Hyperlordotic ALIF Interbody Spinal Fusion System. Tesera SA is a porous titanium stand-alone anterior lumbar interbody fusion system featuring a four-screw design and a locking cover plate to prevent screw backout. Implants are now available in 7˚, 12˚, 17˚, 22˚ and 28˚ lordotic angles with varying heights and footprints for proper intervertebral height and lordosis restoration, along with advanced instrumentation designed to reduce operative steps. All Tesera implants utilize additive manufacturing (3D printing) and a proprietary, patent-pending design to create a roughened, highly porous surface structure that allows for bone attachment and in-growth to the implant, maximizing strength, stability and biologic fixation. Renovis now offers multiple 3D-printed, porous titanium implant systems for interbody spinal fusion, including anterior cervical, anterior lumbar, as well as posterior lumbar options. For more information on the Tesera porous structure, visit www.teseratrabeculartechnology.com, or visit the company website to learn about our systems for spine, total joint replacement and trauma applications at www.renovis-surgical.com. About Renovis Surgical Renovis Surgical Technologies, Inc. was founded in 2009 with the mission to be a leading manufacturer of advanced medical devices, striving to continuously exceed customer expectations in service, quality, reliability, and value. The company is headquartered in Redlands, California, with engineering & manufacturing operations in Austin, Texas. For additional information on the Company, please visit www.renovis-surgical.com. Media Contact: email@example.com, 1 (800) RENOVIS SOURCE Renovis Surgical Technologies, Inc. (PRNewsfoto/Renovis Surgical Technologies)
Related Linkshttp://www.renovis-surgical.com Read More
June 27, 2018
PARIS--(BUSINESS WIRE)--Regulatory News:EOS imaging (Paris:EOSI) (Euronext, FR0011191766 - EOSI - Eligible PEA - PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the installation of an EOS® imaging system at ATOS Klinik Heidelberg, establishing it as first private practice in Germany to offer the low-dose 2D/3D imaging system. The system will be available at the spinal surgery center, Zentrum für Wirbelsäulenchirurgie, a private practice led by Dr. Bernd Wiedenhöfer and Dr. Stefan Matschke, two specialists with 20 years of experience in spine therapy each. The practice specializes in non-surgical and surgical treatments of spinal disorders, providing diagnosis and therapy through cutting-edge medicine and state-of-the-art equipment, with an emphasis on patient safety. “EOS imaging utilizes advanced scanning technology to allow ultra-low dose imaging of the entire body,” commented Dr. Wiedenhöfer. “Within a few seconds, the system provides a comprehensive overview of the patient in with up to 90% less radiation than a conventional X-ray and 100% reproduction of the ratios and angles. The resulting benefits for diagnosis and therapy of spinal pathologies are immense, and we are thrilled to now offer this vital technology.” “Because the EOS® system provides a full-body 2D and 3D images, the patient can be assessed as a whole, which is not possible with a traditional X-ray,” added Dr. Matschke. “EOS® allows to accurately determine clinical parameters such as pelvic obliquity or sagittal disbalance, with valuable advantages for enabling physicians to provide the best treatment plans possible for our patients.” “We have been working to expand the use of the EOS® system in private practices, which serve a significant patient population, as we feel it is important to also offer safe and effective imaging to patients outside the traditional hospital setting,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “This installation is particularly important for EOS, as it is the first private practice to offer the system in Germany, a key market for us with notable precedent for adopting advanced technologies.” About EOS imaging 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 31 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 250 installed EOS® platforms representing around 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. EOS imaging is listed on Compartment C of Euronext Paris ISIN: FR0011191766 - Ticker: EOSI
ContactsEOS imaging Marie Meynadier CEO Ph: +33 (0)1 55 25 60 60 firstname.lastname@example.org or Press Relations (US) Joanna Zimmerman The Ruth Group Ph: 646-536-7006 email@example.com or Investor Relations (US) Matt Picciano / Emma Poalillo The Ruth Group Ph: 646-536-7008 / 7024 EOS-imagingIR@theruthgroup.com
NanoFUSE Biologics LLC Appoints Experienced Orthobiologics Executive Archie Yamada to Accelerate Global Revenue Growth
BOSTON (PRWEB) JUNE 27, 2018
NanoFUSE Biologics announced the addition of executive Archie Yamada to the team, a trained sales and marketing professional with 19+ years in the medical device industry with a focus on orthobiologics, orthopedic trauma/joints, and neurosurgical and craniomaxillofacial implants. He joins the NanoFUSE team as VP Product Business Development.
"Throughout my career, I've been heavily involved in the development and sales of orthopedic implants. While I enjoyed providing hardware implants to surgeons, what really motivates me is providing biologic solutions to meet patient needs," said Yamada.
Yamada graduated with an MBA and honors in operations management from the University of Colorado, and a Bachelor of Arts in economics from Brigham Young University. He previously held positions as the Clinical Sales Director for Biologics & Cellular Technology at OsteoMed, Regional Sales Manager for Western U.S. & Canada at Skeletal Kinetics, Consultant and Regional Distributor for DePuy Synthes, as well as Asia Pacific and U.S./EU Sales Manager for Japan Medical Dynamic Marketing and Ortho Development respectively.
"With NanoFUSE, I was offered the opportunity to collaborate with a team dedicated to supplying cutting edge osteopromotive synthetics. Although this itself is interesting, upon learning NanoFUSE's direction of not only staying at the forefront of cellular technology, but advancing and defining the biologics of tomorrow, I was 'all in,'" said Yamada.
The NanoFUSE Biologics platform has the only FDA cleared combination of demineralized bone matrix (DBM) and synthetic bioactive glass technology, providing both osteoinductive and osteoconductive properties. The NanoFUSE DBM putty has been used successfully in +1000 cases by +200 surgeons in various orthopedic applications.
“The NanoFUSE acquisition was a strategic addition to our orthopedic and spine portfolio to provide surgeons a comprehensive product offering. Archie’s leadership is timely as we focus on accelerating revenues and establishing distribution in the U.S. and overseas. We expect strong market demand to continue with attractive returns for our investors, and are encouraged by the recent partnership by DePuy Synthes for Prosidyan’s FIBERGRAFT synthetic product,” said KICVentures Managing Partner & CFO Aditya Humad. NanoFUSE Biologics LLC is a KICVentures portfolio company.
About NanoFUSE Biologics LLC
The NanoFUSE Bioactive Matrix is a unique and proprietary blend of demineralized bone matrix (DBM) that combines the osteoinductive capabilities of DBM with the osteostimulative properties of bioactive glass. NanoFUSE Biologics LLC is a KICVentures portfolio company, distributed by SpineFrontier.Read More
IRVINE, Calif., June 27, 2018 (GLOBE NEWSWIRE) -- GS Solutions Inc., DBA GS Medical USA (GSM), a leader and innovator of surgeon-driven spinal technology that advances patient care, today announced the launch of the AnyPlus® Extended Tab Minimally Invasive Pedicle Screw system.The AnyPlus® Extended Tab Minimally Invasive Pedicle Screw System was engineered to offer a less invasive surgical option for pedicle screw placement. The system incorporates anatomically driven solutions and ergonomic designs that allow for a simple, precise and efficient solution to spinal fixation, adding benefits to minimally invasive approach with less OR time. “Getting the right feedback and insight from surgeon partners is at the forefront of our research and development,” Andrea Watt, Product Development Manager said. “We believe surgeons can drive engineering to develop cutting edge implants and instrumentation that continue to revolutionize the spine industry because they have the right experience and insight for the products and procedures.” Succeeding the Q4 2017 launch of the AnyPlus® Direct Lateral Interbody Fusion system and the Anterior and Posterior Disc Prep Sets, both of which are currently being used successfully in surgeries, GSM experienced a strong start to the year with sales growth in Q1 2018 versus Q1 2017. “As we continue to expand our portfolio of spinal solutions with innovative technology and build out a robust national distributor network, we expect to see solid, positive growth throughout the remainder of 2018,” said James Shin, CEO. To complement the company’s expanding portfolio of solutions, GSM hosted a cadaver lab and bioskills course in early May in Las Vegas. The course featured presentations by current GSM surgeon users, and attendees were provided with technical, hands-on training on the various systems offered by GSM. The surgeons who attended expressed positive feedback on both the DLIF and percutaneous systems, as well as the strategic direction of the company. “Given the rapid expansion of our portfolio of solutions, we recognize the continued need to partner with our surgeons and distributors to provide expert instruction on our spinal systems,” said Kurt Neesley, U.S. Sales and Business Development Director. “We are committed to a platform for multi-faceted surgeon education, and we value the opportunity to collaborate with surgeons in a cadaveric setting,” Kurt said. “We look forward to working with surgeons and distributor partners to improve patient care with our new and advanced products and technology." GSM leadership and sales representatives plan to exhibit at NASS, September 26-29. To schedule a meeting with the team or to inquire about distributor partnership opportunities, please contact firstname.lastname@example.org.
Media Relations Contact: Amanda Collins I Phone: 949.380.6385 x213 FAX: 866.600.9712 6 Wrigley Irvine, CA 92618 www.gsmedicalusa.comRead More
- Increase in government expenditure for the development of ambulatory facilities to increase accessibility and reduce treatment cost is expected to propel the market
- Primary care offices accounted for the largest share of the market in 2016 due to cost-effective treatment and easy accessibility for diagnosis & treatment
- Surgical specialty is anticipated to be the fastest-growing segment in the forecast period due to increase in the demand for minimally invasive procedures. In addition, the preference of patients for nonsurgical and minimally invasive surgeries has led to the growth of plastic surgery centers. According to American Society of Plastic Surgeons, in 2016, 7.6 million cosmetic procedures were performed on people aged between 40 and 54 years. In 2016, United Nations spent more than 15 billion dollars on esthetic surgical and nonsurgical procedures
- Based on the region, North America held the largest market share and is expected to retain its dominance during the forecast period due to increase in the number of advanced diagnostic methods and rise in the number of cases related to orthopedics, ophthalmology, gastroenterology, plastic surgery, and chronic pain
- The Asia Pacific region is likely to witness significant growth over the next decade due to increase in the incidence of angle closure glaucoma & myopia, increase in life expectancy, and growth in recognition of the need to develop emergency care outside traditional hospital settings
- Some of the key players are Surgery Partners; Envision Healthcare; IntegraMed America, Inc.; Symbion, Inc.; Terveystalo; NueHealth; Aspen Healthcare; and Medical Facilities Corporation
- Vitamin D Testing Market - The global vitamin D testing market size was estimated at USD 498.1 million in 2016.
- Cancer Biomarker Market - The global cancer biomarker market size was valued at USD 10.3 billion in the year 2016.
- Biopsy Devices Market - The global biopsy devices market size was estimated at USD 1.0 billion in 2016.
- Lung Cancer Therapeutics Market - The global lung cancer therapeutics market is expected to grow significantly over the forecast period.
- Ambulatory Services Type (Revenue, USD Million, 2014 - 2025)
- Primary Care Offices
- Emergency Departments
- Surgical Specialty
- Pain Management/Spinal Injections
- Plastic Surgery
- Medical Specialty
- Ambulatory Services Regional Outlook (Revenue, USD Million, 2014 - 2024)
- North America
- Asia Pacific
- South Korea
- Latin America
- Middle East & Africa
- South Africa
- Saudi Arabia
- United Arab Emirates
- North America
The Global Cartilage Repair Market size is expected to reach $7 billion by 2024, rising at a market growth of 5.6% CAGR during the forecast period
June 26, 2018