Semi-Automated Design Program Could Develop Patient-Specific Knee Implants

Stellenbosch University – 06.19.18

People whose knees have been affected by osteoarthritis, also known as the “wear and tear” arthritis, often have to get knee implants to repair the damage. But if a knee implant does not fit the specific individual, it could lead to soft tissue damage, collapsing of the underlying bone, loosening of the implant and an increased likelihood of joint pain after an operation.

“One possible solution is to design implants that are patient-specific, anatomically accurate, reproduce normal knee motion and are ultimately repeatable,” said Dr. Johan van der Merwe, a lecturer in the Department of Mechanical and Mechatronic Engineering at Stellenbosch University (SU). Van der Merwe, who is also a member of the Biomedical Engineering Research Group in the same department, recently obtained his doctorate in Mechatronic Engineering at SU. He focused on developing a repeatable, semi-automated method of generating patient-specific implant components that reproduces an individual’s healthy anatomy to facilitate natural joint movement after an operation.

Van der Merwe pointed out that the knee is one of the joints most susceptible to osteoarthritis, a form of arthritis that occurs when the protective cartilage in joints breaks down.

Van der Merwe said for localized osteoarthritis, surgical reconstruction or replacement of only the damaged part of the knee (Unicompartmental Knee Arthroplasty) may be preferred over the replacement of the entire joint (Total Knee Arthroplasty). Projections are that by 2030 three million knee replacement surgeries will be done globally. Current knee replacements usually last for 10 years.

“Replacing or repairing only the damaged part may result in faster recovery, improved post-operative joint movement, retains as much of the joint’s natural anatomy as possible and is done at a lower cost,” he said. “But designing patient-specific Unicompartmental Knee Replacements ultimately rely on a technician’s interpretation and skill in order to consistently reproduce healthy knee shapes. This is a difficult problem—what is considered healthy for one patient might not be the same for another.”

Van der Merwe pointed out that there is often a mismatch between current standardized sizes of commercially available implants and the shape and form of an individual patient’s knee. This generally requires the surgeon to make the patient fit the implant, and sometimes even deviate from the ideal intended implant placement based on experience and current best practices to achieve good outcomes.

In an attempt to address these shortcomings, Van der Merwe developed a model based on the various shapes of healthy knees, which could then be used to estimate the healthy shape of damaged parts on a patient’s knee.

 

READ THE REST HERE

 

Image courtesy of Dr. Johan van der Merwe

 

Exactech Earns Research Award at International Computer-Assisted Surgery Conference for ExactechGPS® Knee Application

June 20, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, earned the Second Place Best Clinical Podium Presentation Award for one of five new research studies presented on the company’s latest computer guidance technology for knee surgery at the International Society for Computer Assisted Orthopaedic Surgery (CAOS) annual meeting in Beijing, China earlier this month.

The award-winning research demonstrated the potential for ExactechGPS to accurately manage soft tissue balance, bone cuts and overall alignment of the knee in joint replacement surgery.

According to Orthopaedic Surgeon David Liu, MD, of The Gold Coast Centre for Bone & Joint Surgery in Queensland, Australia, “It was an honour to present several studies based on ExactechGPS and to receive this award, along with my co-authors Yifei Dai and Guillaume Bras of Exactech. This scientific meeting is unique in its focus on the role of navigation in orthopaedic surgery. I am confident that this technology plays a major role in the outcomes of joint arthroplasty.”

The five ExactechGPS studies presented at CAOS 2018 add to the more than 20 presented so far this year, including one that was recognized as the 2018 Orthopaedic Research Society’s Best Implant Poster Award. For more information on Exactech’s solutions for knee replacement and its ExactechGPS technology, visit www.exac.com.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

Contacts

Exactech
Media Contact:
Priscilla Bennett, 352-377-1140
VP of Marketing and Corporate Communications, Exactech
media@exac.com

InVivo Therapeutics Announces Pricing of $13.2 Million Underwritten Public Offering

June 21, 2018

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced the pricing of an underwritten public offering of 388,403 shares of its common stock, together with warrants to purchase 388,403 shares of common stock at a combined price to the public of $2.00 per share and warrant, as well as pre-funded warrants to purchase up to an aggregate of 6,242,811 shares of common stock together with warrants to purchase 6,242,811 shares of common stock, at a combined price to the public of $1.99 per pre-funded warrant and warrant. The gross proceeds from this offering are expected to be $13.2 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by InVivo Therapeutics.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE American:LTS), is the sole book-running manager in connection with the offering.

Each warrant has an exercise price of $2.00 per share, is exercisable immediately and expires five years from the date of issuance. Each pre-funded warrant has an exercise price of $0.01 per share, is exercisable immediately and will expire twenty years from the date of issuance. The pre-funded warrants issued in the offering include a beneficial ownership blocker and the holders do not have the rights or privileges of holders of common stock, including any voting rights, until they exercise the pre-funded warrants. As of June 20, 2018, InVivo Therapeutics had 1,648,349 shares of common stock outstanding. The exercise price of the warrants and the pre-funded warrants is fixed and they do not contain any variable pricing features or any price based anti-dilutive features. The offering is expected to close on or about June 25, 2018, subject to customary closing conditions.

A registration statement (File No. 333-224424) relating to these securities has been filed with the Securities and Exchange Commission, or the SEC, and was declared effective by the SEC on June 20, 2018 and an additional registration statement filed pursuant to Rule 462(b) (File No. 333-225768), which became effective when filed. The offering will be made only by means of a prospectus, which is part of the effective registration statement. When available, copies of the final prospectus may be obtained from Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In January 2018, the company announced updated clinical evidence, including improvements in patients with acute spinal cord injury (SCI), from its INSPIRE study of the Neuro-Spinal Scaffold™. The publicly traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

SAGICO Announces 510(k)-Pedicle Screw Clearance for its OSI Spinal System

June 13, 2018 / James J Gibson, Jr, PhD, CPA, President at SAGICO

The USA FDA has issued SAGICO another 510(k) for its pedicle screw system, branded and marketed as the OSI Spinal System. The technology in the OSI Spinal System include constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors, and associated surgical instruments. The OSI Spinal System implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. SAGICO’s OSI Spinal System implants are designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.

Among the surgical usages for the OSI Spinal System, they are intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the SAGICO OSI Spinal System is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

  • Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
  • Spondylolisthesis;
  • Spinal stenosis;
  • Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
  • Pseudarthrosis; and
  • Failed previous fusion

SAGICO’s OSI Spinal System were cleared to market by the FDA under a variety of Product Codes to include; Thoracolumbosacral Pedicle Screw System (NKB), Appliance, Fixation, Spinal Intervertebral Body (KWQ) and Appliance, Fixation, Spinal Interlaminal (KWP)

MORE ABOUT SAGICO: Spinal Analytics & Geometrical Implant Co, (SAGICO) and its principals have many years of spinal industry success spanning multiple continents in more than 60 countries. SAGICO and its affiliates are privately held companies with global partners and shareholders and an aggressive pipeline that includes: novel artificial disk implants (TDR), Porous Titanium interbody technology, Expandable VBR options and unique Pedicle Screw Systems optimized for Complex & Pediatric surgery are just a few of the product lines SAGICO offers. SAGICO’s USA corporate based operations are located in Tampa, Florida.

DISCLOSURE: We at SAGICO are confident in our products and so should our professional surgeons. A surgeon must always rely on his or her own clinical judgment when deciding whether to use a particular medical appliance that may be applicable for a specific patient and adhere to the package insert, product label and/or instructions for use before using any SAGICO product. SAGICO does not diagnose nor does SAGICO offer medical advice on medical conditions and SAGICO requires that all surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the depth and future of all of SAGICO’s product lines. Some products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact SAGICO prior to any medical procedures to learn more.

Learn more @: www.SAGICO.co

To schedule an interview please contact SAGICO in the USA: Telephone: 813-830-3636

Limited USA and International Distributor Opportunities Remain

WishBone Medical, Inc. announces Randal R. Betz, M.D. as Chief Medical Officer

WARSAW, Ind., June 20, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc. is pleased to announce the appointment of Randal R. Betz, M.D. as Chief Medical Officer. Dr. Betz, on a part time consulting basis, will provide strategic expertise and guidance for the company’s product portfolio, support professional education and help with key opinion leader relationships consistent with WishBone Medical’s objectives.

Dr. Betz earned a Medical Degree from Temple University School of Medicine. His internship in general surgery and residency in orthopaedics was at Temple University Hospital. Dr. Betz’s fellowship in Pediatric Orthopaedics was at the Alfred I duPont Institute. He is a Pediatric Orthopedic Surgeon with a focus on Pediatric Deformity Correction.

He formerly was Chief of Staff at Shriners Hospitals for Children in Philadelphia. His current positions include a Private Practice at the Institute for Spine and Scoliosis in Lawrenceville, NJ, Clinical Professor at Mount Sinai Medical Center in New York City and Attending Surgeon at Mount Sinai Hospital in New York City and Saint Peter’s Children’s University Hospitals in New Brunswick, NY.

Research and product development is important to Dr. Betz. He has 17 patents. He belongs to several national and international professional societies. He has published 5 books, authored many medical texts and books; including 52 chapters for medical books and written 330 peer-reviewed articles.

Nick Deeter, Chairman of the Board and CEO at WishBone Medical, said, “We look forward to working with Dr. Betz on pediatric orthopedic products designed just for kids. He is well known and respected for his pediatric orthopedic expertise around the world.” Mr. Deeter added, “With his extensive background and experience, he will help build our surgeon teams and focus our strategic direction on helping children globally with orthopedic issues.”

About WishBone Medical, Inc.

WishBone Medical is a Global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing

For further information, visit WishBoneMedical.com or call Andrew Miclot, Vice-Chairman and President at 574-306-4006.

Zavation Medical Products Announces Brian K. Hutchison as Newest Member of its Board of Directors

JACKSON, Miss.June 20, 2018 /PRNewswire/ — Zavation Medical Products (“Zavation” or “the Company”), a LongueVue Capital Partners (“LVC”) portfolio company that designs and manufacturers high-quality spinal implants, instruments, and biologics, announced today that Brian K. Hutchison has joined its Board of Directors.

Zavation Chairman and LVC Managing Partner Rick Rees stated, “My colleagues and I are excited to welcome Brian to the Zavation family. His extensive relationships and leadership experience building orthopedic and spine businesses, first at Stryker and then as CEO of RTI Surgical, will be an invaluable resource to our team. Ultimately, his relationships are a testament to his character, which makes him a great addition to the Board of Directors. We look forward to benefiting from his accomplished career within the orthopedics and spine industry.”

“Brian has been in our shoes before and will serve as a valuable strategic resource as Zavation continues to grow,” said Jeffrey Johnson, Founder and CEO of Zavation. “But, more importantly, Brian is a cultural fit who shares our vision and understands that our priority is providing excellent customer service and quality products.”

Hutchison added, “I am delighted to join Zavation, a high growth and innovative spine company with a full-bag of products. I’ve admired Jeffrey and his team for many years, as they’ve managed remarkable growth without sacrificing customer service. I look forward to supplementing the team to further accelerate the Company’s growth trajectory.”

Hutchison brings 30 years of healthcare industry experience with him to Zavation. Most recently, Hutchison retired after serving 15 years as the Chief Executive Officer of RTI Surgical, Inc. (NASDAQ: RTIX). At RTI Surgical, he grew annual revenue from $55 million to $300 million, positioning the company as a leader in advanced biologic products. As CEO, Hutchison successfully merged RTI Surgical with Tutogen Medical in 2013 and subsequently acquired Pioneer Surgical Technologies. From 2014 to 2016, RTI Surgical was recognized as one of the fastest-growing spine companies in the world, with nearly 20% quarter-over-quarter growth.

Before RTI Surgical, Hutchison held various positions at Stryker Corporation, including serving as President of its Medical Division and Vice President of Worldwide Product Development and Distribution.

Hutchison currently serves on the Board of Directors of the University of Florida Research Foundation. He received a BBA with a focus in Accounting from Grand Valley State University in 1981 and attended Harvard Business School’s Program for Management Development in 1995.

ABOUT ZAVATION MEDICAL PRODUCTS

Based in Jackson, MS, Zavation designs, engineers, and manufactures a portfolio of spinal hardware covering key areas including thoracolumbar, cervical, interbody fusion, minimally invasive surgery, and vertebral compression fractures. Founded in 2010 with its first sale in 2012, the Company has experienced exceptional growth and created a national network of over 200 distributors across approximately 40 states. Zavation has commercialized over 12 product families since inception, with 10 additional novel products expected to launch over the next year. The Company operates a 24,000 square foot vertically integrated manufacturing facility with 70 employees.

To learn more information about Zavation and its products, visit www.zavation.com

ABOUT LONGUEVUE CAPITAL

LongueVue Capital is a private equity firm focused on making situation-driven, value-oriented investments in lower middle market companies (up to $150 million in annual revenue) to support buy-outs, recapitalizations, acquisitions, and growth. LVC currently has $425 million under management across two funds. Since its formation in 2001, LVC has made successful investments in a wide variety of industries, including healthcare, business services, transportation and logistics, energy services, and niche manufacturing. LVC is based in New Orleans with additional offices in New York and Salt Lake City. For more information, please visit www.lvcpartners.com.

SOURCE LongueVue Capital Partners

Related Links

http://www.lvcpartners.com

Stimwave Appoints Industry Veteran Steven Amelio as Chief Financial Officer

June 19, 2018

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.

Contacts

Glodow Nead Communications
Rosemary O’Brien and Sarah Rogers, 415-394-6500
StimwavePR@GlodowNead.com

Positive Knee Preservation Outcomes Using the Innovative Arthrosurface Inlay PF Wave™

FRANKLIN, Mass.June 19, 2018 /PRNewswire/ — Arthrosurface, Inc. announced today that midterm clinical results reconfirmed joint preservation in patellofemoral (PF) surgery with the PF Wave™ Implant System. 5-year results presented by Dr. Jonas Pogorzelski at the recent ESSKA Congress in Glasgow, Scotland found significant improvement in symptoms and no progression of knee arthritis.

Isolated patellofemoral arthritis occurs when there is loss of cartilage limited to the central portion of the knee joint. For advanced stages, partial joint replacement has become the leading treatment. The Arthrosurface PF Wave Inlay Arthroplasty Design adapts and restores the patient’s unique joint surface providing a novel, anatomic approach to treating isolated patellofemoral arthritis. Derek Jones, MD, Section head of Sports Medicine and Cartilage Restoration at the Ochsner Sports Medicine Institute in New Orleans said, “Over the course of the past 8 years, I have been very encouraged seeing my patients return to high levels of work and sports following this procedure. Our joint preservation experience is similar to those presented at ESSKA.” In contrast, traditional Onlay implants require more extensive bone cuts and tend to sit high on the new joint surface, thereby increasing the risk of overstuffing the joint.

Based on their findings presented at ESSKA, lead author Prof. Andreas Imhoff, Professor of Orthopaedic Surgery and Traumatology, Director/Chairman Department of Orthopaedic Sports Medicine at the University of Munich concluded, “We observed significantly improved postoperative outcomes with high patient satisfaction at the two-year follow up. This trend held true for the 5-year results, too.”

According to Matthias Schurhoff, VP of Clinical Affairs, “seeing these study results continue to show no arthritic changes at the 5-year mark while holding significant pain relief and functional improvement is very validating for us. These results support our belief that our unique inlay concept provides a contemporary arthroplasty track in patellofemoral surgery.”

Arthrosurface continues to innovate Patellofemoral Arthroplasty by providing active alternatives to total knee replacement and allowing more patients access to knee preservation options.

About Arthrosurface: Arthrosurface, Inc. is a global orthopedic medical technology business providing a broad portfolio of essential products and instrumentation used to treat upper and lower extremity orthopedic conditions caused by trauma, injury and arthritic disease. Arthrosurface is the inventor and market leader in joint preservation with inlay arthroplasty. Our product offerings include joint preservation implants, instruments and orthobiologics. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world and has succeeded in helping patients return to activity for over 14 years. For more information, please visit our website at www.arthrosurface.com

SOURCE Arthrosurface, Inc.

Related Links

http://arthrosurface.com

Kuros Biosciences to present promising clinical case studies with MagnetOs at leading spine surgery conference

Schlieren (Zurich), Switzerland, June 19, 2018

Kuros Biosciences will this week present results from several investigator-led clinical case studies of MagnetOs Granules at the 15th annual State of Spine Surgery Think Tank, a leading conference uniquely dedicated to innovation in spinal surgery.

The case studies, in which MagnetOs Granules were implanted in the spine, were performed by Alwyn Jones MB ChB, BSc, MSc, FRCS, FRSC (Orth), Consultant Orthopaedic Spinal Surgeon at Spire Cardiff Hospital in the UK.

The key clinical outcomes at six months were improved back and leg pain. The most important fusion outcomes were good incorporation of MagnetOs in the posterior fusion bed, graft resorption and remodelling to bone, and progression towards fusion.

Key takeaways from the case studies were:

  • MagnetOs Granules were well‐tolerated and no device related adverse events were reported in the small cohort of patients requiring spinal fusion
  • MagnetOs Granules were easy to apply as a stand‐alone graft or when mixed with bone marrow aspirate (BMA) or local bone
  • Resorption and remodelling of MagnetOs Granules was evident from as early as 3 months post‐implantation
  • MagnetOs Granules promoted spinal fusion in a mixed cohort of patients when implanted using 5 different surgical approaches

Alwyn Jones said: “I implanted MagnetOs in a cohort of five patients requiring spinal fusion in 2017 and I’m very pleased with their progress. In all cases, my radiographic data indicated remodelling of MagnetOs and progression towards a fusion. All five patients had a reduction in pain, improvement in disability index and improved clinical symptoms compared to their pre-surgical assessment. This initial experience has encouraged me to use MagnetOs in my broader clinical practice.”

Joost de Bruijn, Chief Executive Officer of Kuros, said: “The results from these investigator-led clinical case studies with MagnetOs are very gratifying and underline the interest of the clinical research community in our CE marked product. The MagnetOs Granules were easy to apply and showed clear clinical benefits for patients, giving them an improved quality of life with less pain.”

MagnetOs promotes local bone formation equivalent to current gold standard, autograft. MagnetOs is a bone graft substitute intended to fill bony voids or gaps of the human skeletal system and promote the formation of bone at the implanted site. A substantial number of clinically relevant and predictive studies have demonstrated its equivalence to the current gold standard (patient’s own bone, which may not be available in sufficient quantities and/or involves morbidity, costs and pain associated with its harvesting from another healthy site of the patient’s body). MagnetOs is a bone graft comprising biphasic calcium phosphate with an advanced submicron surface topography that directs bone formation after implantation. With its unique submicron surface topography, MagnetOs preferentially directs early wound healing toward the bone-forming pathway, resulting in an osteoinductive claim in Europe. MagnetOs is available as granules and as a putty formulation.

The State of Spine Surgery Think Tank, formerly known as the Cabo Meeting, takes place June 21-13 in Aruba.

For further information, please contact:

Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

Media & Investors
Hans Herklots
LifeSci Advisors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG

Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline.

Forward Looking Statements

This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

News release (pdf)

Kuros Biosciences Ltd, Wagistrasse 25, CH-8952 Schlieren

Anika Therapeutics Announces Top-Line Results from CINGAL 16-02 Clinical Trial in Knee Osteoarthritis

June 19, 2018

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.govForward-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.

Contacts

For Investor Inquiries: Anika Therapeutics, Inc.
Sylvia Cheung, Chief Financial Officer, 781-457-9000
or
For Media Inquiries: Pure Communications
Sonal Vasudev, 917-523-1418 sonal@purecommunicationsinc.com