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 its EOS® system at the University Hospital Center of Grenoble Alps (CHUGA), a state-of-the-art hospital facility for osteoarticular surgery in children and adults. CHUGA is the 20^th university hospital center to acquire an EOS® system, and the new system will be dedicated to the center’s clinic as well as to clinical research activities.

With more than 2,100 beds, CHUGA employs nearly 8,000 professionals, including 1,700 doctors. It has an advanced technical platform and provides highly specialized care. The center’s teams are recognized for their excellence in orthopedic surgery, particularly in the field of advanced surgical techniques assisted by navigation or robotics.

The new EOS system will be located in the pediatric radiology department within the pediatric section of the hospital. It will be used in the care of both pediatric and adult patients through a collaboration with two adult orthopedic services located in the North and South Poles of CHUGA.

“The EOS system will allow us to further develop the clinical care of our pediatric patients through imaging at low radiation dose. It will also significantly accelerate our collaborative research programs with EOS on the orthopedic treatment of scoliosis with braces,” commented Professor Aurélien Courvoisier, Pediatric Orthopedic Surgeon.

“We are very pleased to serve the Grenoble Hospital Center for clinical and research applications,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “The patient has always been our main concern as we work to spread low-dose, 2D/3D imaging capabilities. EOS has changed the care of osteo-articular pathologies and has become a standard thanks to lower radiation, higher accuracy, and 3D imaging of the full body, all of them valuable in choosing the most effective treatments, preparing surgical intervention, as well as in post-operative follow-up. On the research side, we hope to open new perspectives on the treatment of spinal deformities with braces, and will also pursue collaborative programs on the integration of the EOS examination data in the operating room.”

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

POMPANO BEACH, Fla.–(BUSINESS WIRE)–Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, today announced the appointment of industry veteran Steven Amelio to the position of Chief Financial Officer (CFO).

Amelio is a senior financial executive with 30 years of experience in the medical device industry. Over his 20 year career with United States Surgical Corporation, Tyco Healthcare Group LP and ultimately Covidien, PLC he rose through the finance department in various roles and spent 10 years as Divisional CFO of Surgical Devices. With his broad- based knowledge of the industry and operations, Amelio was involved in all aspects of many acquisitions, divestitures, and purchased technologies in surgical areas such as minimally invasive, electro-surgery, orthopedic, biologics, and other related areas in addition to overseeing global finance organizations.

“Steven’s demonstrated strong healthcare and medical device track record and hands on finance experience make him the perfect fit for Stimwave to enhance our strategic plans,” said Laura Tyler Perryman, co-founder and CEO of Stimwave. “The addition of Steven strengthens our executive management team to support our high growth and to meet the market demand for our innovative and game changing neuromodulation platform technology.”

With 10 years of private equity experience in medical device companies, most recently, Amelio was CFO of Paradigm Spine, LLC, a private equity medical device company located in New York City where he was recognized in Becker’s Spine Review as an Industry Leader to Know. Amelio has an MBA in Finance and a BBA in Accounting from Iona College in New York.

“Stimwave’s technology provides beneficial alternatives to millions of patients suffering from chronic pain annually, as well as the healthcare system overall. I was fortunate to witness the positive impact new technologies have on patients very early in my career at United States Surgical Corporation and look forward to being part of the Stimwave team as we launch and embark on global commercialization and rapid growth,” said Amelio.

Stimwave’s devices use Wireless Pain Relief^® technology and are 95 percent smaller than any other neuromodulation device on the market and can be fixated through an injectable method. The device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. Stimwave is the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.

About Stimwave

Stimwave Technologies Incorporated is a privately held medical device company engaged in the development, manufacturing, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective pain management solution that is easily incorporated into their daily lives. Stimwave’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of pain management. www.stimwave.com

Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements.

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (HA) technology platform, today announced results from its CINGAL^® 16-02 clinical trial, an active-comparator Phase III study being conducted to support U.S. registration. CINGAL has previously been evaluated in a placebo-controlled Phase III clinical trial (13-01) that demonstrated safety and efficacy through 26-weeks. The 16-02 trial compared CINGAL, a combination of cross-linked HA and triamcinolone hexacetonide (TH), with TH alone and cross-linked HA in treating patients with osteoarthritis (OA) in the knee. The primary endpoint was a comparison of the pain reduction of CINGAL compared with TH alone at 26-weeks. While CINGAL achieved greater pain reduction numerically at every time point in the study, the difference at 26-weeks did not reach statistical significance.

The patient response to CINGAL in the study was strong, as significant improvements in pain, function, and quality of life were observed at levels consistent with, and in most cases greater than, the results of the 13-01 placebo-controlled Phase III study of CINGAL. A strong safety profile was also shown, matching previous clinical studies as well as real-world experience from growing product use globally. The duration of pain reduction was also similar to the previous study as patient improvement after CINGAL injection was maintained near peak levels throughout the 26-week duration of the study. Follow-up of patients continues in a prospectively designed extension phase to the study, which will gather data through 39-weeks.

Prof. Laszlo Hangody, MD, Ph.D., DSc., the global principal investigator of several CINGAL trials, said, “While it has been observed that TH has a longer duration of effect than other corticosteroids, the results in this study were surprising. Nevertheless, the patient response to CINGAL in this study was strong as patients received statistically and clinically meaningful rapid and long-lasting improvement in symptoms compared with base-line, consistent with the previous study as well as my experience in my practice. Taken together, the results of the two Phase III studies validate the effectiveness of this novel combination for use in patients with knee osteoarthritis.”

CINGAL is the first and only commercially-available combination viscosupplement, and it is currently being used successfully by physicians to provide rapid and long-lasting relief from pain and discomfort caused by OA for patients in a growing number of countries. CINGAL is a patented formulation composed of the Company’s proprietary cross-linked sodium hyaluronate and triamcinolone hexacetonide. CINGAL is Anika’s third-generation viscosupplement, following the Company’s ORTHOVISC and MONOVISC products, to treat pain associated with osteoarthritis of the knee.

Anika President and CEO Joseph Darling said, “OA patients continue to benefit from the proven safety and efficacy of CINGAL in growing numbers outside of the U.S. where CINGAL is approved. The benefits of combining HA and a corticosteroid are mirrored by physician feedback and real-world experience. While we expected CINGAL to perform as well as it did, we were surprised that the difference in pain reduction seen in this trial did not reach statistically significant levels at six months. We will however, continue to monitor the results of the ongoing 3-month extension study. We are actively reviewing the data and our plan is to work closely with regulators to come to an understanding of the next steps required to gain U.S. regulatory approval of CINGAL. We remain fully committed to bringing this impactful OA solution to U.S. patients and physicians.”

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. is a global, integrated orthopedic and regenerative 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 tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary 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.

ANIKA, ANIKA THERAPEUTICS, CINGAL, HYALOFAST, MONOVISC, and ORTHOVISC are registered trademarks of Anika.

Forward-Looking Statements

The statements made in fifth paragraph of this press release as to the future activities and plans of the Company are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, which reflect the current beliefs and expectations of the Company’s management, may be affected by inaccurate assumptions and by known and unknown risks and uncertainties that are difficult to predict or beyond the Company’s control, including actions and decisions of regulatory authorities. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission and available at www.sec.gov. Forward-looking statements are 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.