Schlieren (Zurich), Switzerland, June 12, 2018

Kuros announced today that the University Medical Center Utrecht (UMCU) in the Netherlands has obtained approval from its ethical committee to start an investigator-led multicenter study comparing MagnetOs with autologous bone in posterolateral spinal fusion.

The study is entitled “A Randomized Controlled Trial of MagnetOs® granules vs. Autograft in Instrumented Posterolateral Spinal Fusion”, with UMCU as principal investigator. UMCU’s Department of Orthopedics is one of the foremost orthopedic clinical research centers in the world. The primary objective is to demonstrate non-inferiority with regard to efficacy and safety of MagnetOs compared to the current gold standard, autograft, harvested from the patient’s own body, in instrumented posterolateral spinal fusion.

The first patients are expected to be enrolled in H2 2018.  

Joost de Bruijn, Chief Executive Officer of Kuros, said: “Spinal fusion is the focus of Kuros’s commercial activity, and this study is expected to generate valuable data to help further differentiate MagnetOs in the bone graft substitute market. It is part of the Kuros philosophy ‘proof what you claim’ and should enhance our competitive positioning.”

Dr. Moyo Kruyt of UMCU, principal investigator of the study said: “We are excited about the prospects of MagnetOs in this study as the solid science underlying MagnetOs has already shown powerful bone generating properties of calcium phosphates with a submicron topography. Replacing patient-own bone with a product like MagnetOs would provide a real clinical benefit.”

Spinal fusion is currently performed by using large amounts of autologous bone graft. A substitute for a patient’s own bone would eliminate the graft harvesting morbidity and associated pain that is one of the main disadvantages of this approach.

About the study

This study is designed as a patient and observer blinded, controlled, randomized, multicenter clinical trial across five centers with intra-patient comparisons. One hundred adult patients qualified for posterolateral spinal fusion in the thoracolumbar and lumbosacral region (T10-S2) will be recruited and enrolled in this study. Primary endpoint is  posterior spinal fusion rate after one year based on CT-scans.

 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.

For further information, please contact:

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.

June 08, 2018

SUWANEE, GA, June 04, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) is excited to announce that Shri Parikh has joined SANUWAVE Health effective May 31, 2018 as President of our Healthcare division. Shri most recently joins us from Molnlycke Health Care where he held the title of Vice President, Sales and Marketing. Prior to Molnlycke, Shri was the Director of National Accounts at Stryker, a leading medical technology company with products and services in Orthopaedics, Medical and Surgical Equipment, and Neurotechnology and Spine.

Shri began his career in sales at Bristol-Myers Squibb and held various roles with increasing sales, marketing and corporate accounts responsibility at Guidant and St. Jude Medical before joining Stryker.

“We are thrilled that Shri chose to join the SANUWAVE family. His leadership, ethics and commercialization expertise will further spearhead the design of a carefully thought out go-to market strategy among other growth management initiatives as we continue to develop partnerships around the globe,” said Chief Executive Officer, Kevin Richardson who further stated, “We enthusiastically look forward to returning more value to our shareholders under Shri’s direction.”

President, Shri Parikh also commented, stating, “I am honored to join the SANUWAVE team and excited about our future.  SANUWAVE’s unparalleled innovative technology and clinical evidence has far reaching implications benefiting patients suffering from diabetic foot ulcers and beyond.  I look forward to working with the talented team at SANUWAVE to deliver sustainable capabilities and scale to support our global growth and commercialization plans, while taking all the necessary steps to enhance value for all shareholders.”

Shri was born and raised in Charlotte, NC. He holds a Bachelor of Arts degree in Medical Ethics and Economics from Davison College, a Master of Business Administration from Jacksonville University and an Advanced Management Program degree from the University of Chicago.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. (OTCQB:SNWV) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating System for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is US FDA cleared for the treatment of Diabetic Foot Ulcers.  The dermaPACE® System is also CE Marked throughout Europe and has license approval for the treatment of the skin and subcutaneous soft tissue in Canada, South Korea, Australia and New Zealand. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® System, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron®, Evotron® and orthoPACE® Systems in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

Contact: 

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
Chairman of the Board
978-922-2447
investorrelations@sanuwave.com

Schlieren (Zurich), Switzerland, May 31, 2018 – Kuros Biosciences (SIX: KURN) will propose the appointment of CEO Joost de Bruijn, as well as three new independent non-executive directors at its 2018 Annual General Meeting (AGM) on 14 June. 

Shareholder approval will be sought for the appointment of Joost de Bruijn, Chief Executive Officer of Kuros. Dr. de Bruijn has more than 28 years of experience in academia and the life science industry. He was the founder and CEO of Progentix Orthobiology and more recently of Xpand Biotechnology. He is Professor of Biomaterials at Queen Mary University of London, UK, and Professor of Regenerative Medicine and Entrepreneurship at Twente University, The Netherlands. 

Jason Hannon, Chief Executive Officer and Member of the Board of Directors of Mainstay Medical SA, is proposed to replace Didier Cowling, who will not stand for reelection. Mr. Hannon has extensive experience in the healthcare and medical devices industry, particularly related to commercialization of new products, penetration of new markets, product innovation, strategic and financial planning, raising capital, regulatory and clinical management, and the building of a high-performance culture. Mr. Hannon previously served as President and Chief Operating Officer of NuVasive (NASDAQ:NUVA), a medical device company focused on the spine market.

Scott P. Bruder, MD, PhD, would replace Frank-Jan van der Velden who will not stand for reelection. Dr. Bruder is an expert in orthobiology and is a seasoned senior executive with a track record spanning more than 25 years at industry leaders such as DePuy Biologics (now Depuy Synthes), Johnson & Johnson Regenerative Therapeutics, LLC, Becton, Dickinson and Company (now BD), and Stryker Corporation.

Oliver Walker would replace Harry Welten who will not stand for reelection. Mr. Walker is a finance executive with more than 20 years of experience covering all aspects of finance including M&A, capital market transactions, treasury, reporting and fundraising. Has was CFO of a number of leading healthcare companies, such as Nobel Biocare, Sonova, and Stratec. Oliver has an MSC in Business Administration & Economics at the University of Berne.

Furthermore, the Board of Directors proposes the re-election of Clemens van Blitterswijk as member, and the election as chairman of the Board of Directors and the re-election of Christian Itin, Leanna Caron, Giacomo Di Nepi and Gerhard Ries as members of the Board of Directors, each for the term until the next Annual Shareholders Meeting.

Documents for the AGM, including the Information Notice with a full agenda, will be made available online on June 1 at: http://www.kuros.ch/investors  

For further information, please contact:

News release (PDF)

CARLSBAD, Calif., May 30, 2018 (GLOBE NEWSWIRE) — International Stem Cell Corporation (OTCQB:ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that a paper prepared by the Company has been published in Volume 12, Issue 5 of the Journal of Tissue Engineering and Regenerative Medicine, a prestigious peer-reviewed scientific journal. Due to its scientific relevance, the article has been featured on the cover of the journal’s May 2018 issue.

The article, entitled “Supplementation of Specific Carbohydrates Results in Enhanced Deposition of Chondrogenic-Specific Matrix during Mesenchymal Stem Cell Differentiation,” discusses a new scalable system developed by ISCO that permits the generation of functional human cartilage tissue derived from the patient’s own skin or fat tissue. This process has the capacity to provide greater stability than other tissue that is currently available for the treatment of osteoarthritis, the most common chronic joint condition.

Using this new system, ISCO scientists generated a healthy cartilage‐specific matrix from human mesenchymal stem cells that had significantly higher viability and cartilage specific properties, including: proteoglycan, aggrecan, hyaluronic acid, and collagen II deposition and glycosaminoglycan production. This new cartilage-specific matrix was built in 3D format and is ready for further therapeutic development.

“While the treatment of Parkinson’s disease has always been at the forefront of our research efforts, we are also pursuing various other therapeutic indications.  In one of those other areas,our R&D Team has significantly improved the process by which we can use the patient’s own mesenchymal stem cells to potentially treat osteoarthritis,” commented Russell Kern, PhD, ISCO’s Executive Vice President and Chief Scientific Officer.  “We are also thrilled to announce that this research gives us a basis to launch program to develop supplements designed to potentially reduce joint pain and improve overall mobility,” he continued.

About Osteoarthritis

According to the Centers for Disease Control and Prevention (CDC), osteoarthritis is the most common form of degenerative joint disease and affects as many as 27 million Americans.

Characterized by progressive erosion of the articular cartilage, osteoarthritis can damage any joint in the body—most commonly in the hands, knees, hips, and spine. The erosion of articular cartilage leads to joint pain, stiffness, and impaired mobility.

Healthy cartilage permits bones to glide over one another. It also absorbs energy from the initial burst of physical movement. In osteoarthritis, the surface layer of cartilage collapses and wears away. This allows bones under the cartilage to rub against one another, causing pain, swelling, and loss of motion of the joint.

About International Stem Cell Corporation

International Stem Cell Corporation (ISCO) is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com),and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

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Safe harbor statement

Statements pertaining to anticipated developments, potential clinical studies , progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

International Stem Cell Corporation
Dr. Russell Kern
EVP, Chief Scientific Officer
(760) 940-6383
ir@intlstemcell.com