31 May

DT MedTech Announces the First US Implantations of the Hintermann Series H2® Total Ankle Replacement Prosthesis

BALTIMOREMay 31, 2018 /PRNewswire/ -- DT MedTech, LLC (DTM) announced today that the first Hintermann Series H2® Total Ankle Replacement Systems have successfully been implanted in patients in the United States. Surgeries were performed, implanting the two-component, semi-constrained total ankle replacement prostheses, at The Johns Hopkins Hospital in Baltimore, Maryland by Dr. James Ficke, Director of Orthopaedic Surgery and Orthopaedist-in-Chief, and at Lakewood Ranch Medical Center in Sarasota, Florida by Dr. James Cottom of Florida Orthopedic Foot and Ankle Center. The Hintermann Series H2® Total Ankle Replacement System is indicated to replace painful arthritic ankle joints due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis). The H2 may also be used as a revision for failed ankle replacements or non-union and mal-union of ankle arthrodesis. It is intended for cement use only in the US. Prof. Beat Hintermann, world-renowned foot and ankle surgeon and developer of the H2, attended the surgeries and said, "I am extremely pleased to be here and observe the implantation of the first H2 ankles in the US. The surgeons did exemplary work and I am confident they will be very satisfied with their patients' outcomes. The H2 design is based on the Hintermann H3* mobile-bearing ankle which has 18 years of positive clinical outcomes. I'm sure these ankles will prove to be the preferred ankle replacement prostheses for surgeons and patients in the United States and around the world." Dr. James Cottom observes, "I believe this implant will be a game changer in ankle arthroplasty and think future clinical studies will demonstrate that it is in a class of its own." David Reicher, President and Chief Executive Officer of DTM, stated, "We could not be more pleased with the H2 surgeries that have recently taken place. With the successful results experienced from more than 40 European implants, we're confident the US success rates will be just as favorable. This exciting, complete ankle replacement system requires minimal bone resection and is designed to capture the axis of rotation which should result in highly reproducible outcomes. We feel it will significantly change the marketplace for primary and revision total ankle replacement surgeries on a global scale. Already available outside of the US, we expect a full US product launch in September of this year, as we continue to focus on intense training for our surgeons." About DT MedTech, LLC DT MedTech, LLC is the parent company of DT MedTech International Limited and European Foot Platform, S.A.R.L. DTM and its subsidiary companies maintain offices in Baltimore, MarylandDublin, IrelandSaint-LouisFrance; and Liestal, Switzerland. As a member of the Data Trace family of businesses, leaders in scientific and medical publishing, surgical training, clinical trial management, medical malpractice insurance, and information services for more than 30 years, DTM provides innovative surgical solutions for lower extremity surgeons with state-of-the-art devices such as The Hintermann Series Total Ankle Replacement Systems. *Please note: Hintermann Series H3™ is not available for sale or distribution within the United States and its territories.

MEDIA CONTACT: Jeannie Sarda DT MedTech, LLC +1 410 427 0003 info@dtmedtech.com

SOURCE DT MedTech, LLC

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31 May

Organogenesis Comparative Effectiveness Research Demonstrating Faster VLU Time to Healing with Apligraf® Showcased at ISPOR

CANTON, Mass. and BALTIMOREMay 31, 2018 /PRNewswire/ -- New comparative effectiveness research from Organogenesis Inc. demonstrating faster time to healing and greater healing rates with Apligraf® for the treatment of venous leg ulcers (VLUs) was showcased last week at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2018 meeting held May 19-23, 2018 in Baltimore, Maryland.
The research, "Comparative effectiveness of a bilayered living cellular construct and an acellular fetal bovine collagen dressing in the treatment of venous leg ulcers," was e-published ahead of print in the peer-reviewed Journal of Comparative Effectiveness Research and showcased during a poster presentation at the meeting. The research was also among a select number of submissions to be considered for ISPOR's Research Poster Awards. To view the published study online, please visit https://www.futuremedicine.com/doi/10.2217/cer-2018-0031. "This is the first Comparative Effectiveness Research study that compares the clinical outcomes of a bilayer living cellular construct (BLCC) and an acellular fetal bovine collagen dressing (FBCD) for the treatment of VLUs in a real world setting," said Michael Sabolinski, MD, lead author of the study. "Improvements in the probability, speed, and incidence of wound closure in VLUs treated with BLCC suggest a greater clinical benefit as well as a potential cost savings benefit." Using real-world data from the Net Health WoundExpert® database – the largest independent source of chronic wound benchmarking data in the industry – researchers compared clinical outcomes for the treatment of VLUs among two treatment modalities: Apligraf, a BLCC that is FDA-approved for the treatment of VLUs, and an acellular fetal bovine collagen dressing. The study found that VLUs treated with Apligraf experienced a 37 percent faster median time to wound closure and that treatment with Apligraf increased the probability of healing by 45 percent when compared to VLUs treated with the acellular fetal bovine collagen dressing. Chronic venous insufficiency affects approximately 2.5 million Americans, with up to 20 percent developing venous ulceration. Individuals who develop VLUs can often experience delayed healing and VLU recurrence. The impact on the patient's quality of life and the economic cost of this disease can be significant; care for VLUs in the United States has been estimated to cost up to $3 billion annually1. "Apligraf is the first approved bioengineered, living cell based product in the United States, and the only PMA approved skin substitute with the indication of healing venous leg ulcers," said Shabnam Vaezzadeh, MD, MPA, Vice President of Global Medical and Clinical Affairs for Organogenesis Inc.  "Organogenesis is committed to empowering healing for patients with VLUs, elevating the global dialogue on health outcomes, and offering therapeutic solutions that facilitate positive clinical outcomes and reduce total cost of care." About ISPOR The leading global professional society for health economics and outcomes research, ISPOR is an international, multidisciplinary society dedicated to advancing the policy, science and practice of pharmacoeconomics and health outcomes research. An unbiased organization comprised of more than 9,500 members from 114 countries, ISPOR and its membership represent the entire field including research, academia, decision and policymaking, payer and patient communities. About Organogenesis Organogenesis Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopedics and spine. Organogenesis's comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs. For more information, visit www.organogenesis.com. *De-identified patient data released to Organogenesis Inc. were consistent with the terms and conditions of Net Health's client contracts and the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Net Health was not involved in the analysis, interpretation, or reporting of the data. 1 https://vascular.org/news-advocacy/venous-ulceration-minimally-invasive-treatment-big-problemJune 15, 2017 Dr. Paul DiMuzio – accessed on May 15, 2018. Media Contact: Angelyn Lowe (781) 830-2353 alowe@organo.com SOURCE Organogenesis Inc.

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31 May

Kuros Biosciences to propose appointment of new Board Members at AGM

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:

Kuros Biosciences AG

Media & Investors

Michael Grau

LifeSci Advisors

Chief Financial Officer

Hans Herklots

Tel +41 44 733 47 47

+41 79 598 7149

michael.grau@kurosbio.com

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

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31 May

Local Surgeon First in Region to Use Groundbreaking Technology for Shoulder Replacement Surgeries

BETHESDA, Md.--(BUSINESS WIRE)--Orthopaedic surgeon Craig Miller, M.D., is now using a new technology to offer patients guided personalized surgery for their total shoulder replacements. ExactechGPS® is the latest advancement in technology that provides surgeons with real-time visual guidance and alignment data in total shoulder surgery. Similar to a navigation device in your car, this advanced platform provides a visual map of the patient’s joint on a screen, allowing surgeons to combine preoperative planning with intraoperative computer-assisted technology, to perform implant alignment specific to the patient’s needs. “This cutting-edge technology allows me to virtually perform the patient’s surgery before going into the operating room,” said Dr. Craig Miller. The technology’s preoperative planning tool allows surgeons to plan their cases in advance of the surgery through a virtual simulation. Surgeons can then execute their plan in real time during the surgery based on a 3-D anatomical model of the patient’s shoulder, making adjustments as needed. ExactechGPS combines surgeon expertise with an advanced computer system to perform the patient’s shoulder surgery with a goal of improved accuracy and precision. Personalized for a patient’s unique bone structure and anatomy, ExactechGPS is designed to allow surgeons to decide where to remove bone and place the shoulder implant in the optimal position. “Every patient’s anatomy is unique, and arthritis or injury can distort the anatomy even more, making an already challenging surgery even more difficult,” Miller said. “With ExactechGPS, I can now plan and execute shoulder replacement surgeries with more accuracy and reproducibility than ever before.” Combined with the Equinoxe® Shoulder System which has demonstrated excellent biomechanics and outcomes in its more than 10 years of use1, surgeons are able to have the best of both worlds – a proven implant foundation1 with today’s most modern surgical technologies. For more information about ExactechGPS or to schedule an appointment with Dr. Miller, call (301) 530-1010 or visit www.sportsdocmiller.com. Additional information about the technology can be found at www.ExactechGPS.com. Dr. Miller completed advanced fellowship training in sports medicine at the Kerlan Jobe Orthopaedic Clinic in Los Angeles, CA where he cared for all major sports teams. His areas of expertise include sports medicine, arthroscopic surgery of the shoulder and shoulder replacement surgery. Dr. Miller adds his ability to perform the first ExactechGPS guided total shoulder replacements in the Washington D.C. area, to numerous first time cutting edge and complex shoulder surgeries in the area. A graduate of Tufts University and George Washington Medical School, Dr. Miller completed his orthopaedic surgery residency at the Hospital for Joint Diseases Orthopaedic Institute / New York University in New York. From 2008-2016, Dr. Miller was an assistant team physician for the Washington Nationals. References: 1. Data on file at Exactech, Inc.

Contacts

Exactech, Inc. Allison Downey, APR, CPRC, 352-377-1140 Marketing Communications Manager allison.downey@exac.com

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31 May

LimaCorporate Celebrating 20 Years of Hip Revision Surgery

SAN DANIELE DEL FRIULI, ItalyMay 30, 2018 /PRNewswire/ -- LimaCorporate is proud to announce that the Revision Stem has achieved 20 years of clinical heritage in the Orthopaedic market. This anniversary consolidates LimaCorporate's strong position in the Revision hip replacement market, also thanks to the combination with the Delta-One TT and Delta-Revision TT, the first 3D Printed Revision cups featuring LimaCorporate's proprietary Trabecular Titanium technology. The only technology that boosts over 10 years of clinical heritage in Orthopaedics.
The Revision Stem allows Orthopaedic surgeons to separate the fixation aspect from biomechanics to provide an ideal stem option for a complex Revision situation. The conical stem design with longitudinal fins is designed to achieve a stable stem fixation, followed by the proper placement of the head with the different proximal body options, enhancing a real intraoperative flexibility. The Delta-One TT and Delta-Revision TT acetabular cups apply the same philosophy even to the acetabular side, thanks to the versatility in reconstructing the biomechanics offered by the spacer system, combined with the Trabecular Titanium proven reliability for the implant primary and secondary fixation. "I started using the Revision Stem due to its simplicity in use and design inspired by the Wagner philosophy, in which a stable implant fixation is achieved through the conical stem profile with finned section. The Revision Stem combines this design with the advantages of the modularity and the wide availability of proximal bodies offered with different heights; its simplicity arises from the combination of different heights of the bodies of the neck with the stem offered with two lengths, allowing to solve the majority of Revision cases, in combination with Delta-One TT and Delta-Revision TT cups", said Prof. Francesco Benazzo, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. The Revision Stem was fully introduced into the market in 1998, and its design is based on the experience gained by LimaCorporate with the LCR stem, released in 1982.  Available in more than 40 countries, the Revision Stem, during these 20 years, continues to represent a valid and solid option for many surgeons dealing with complex Revision surgeries who look for a reliable Revision Stem, supported by several papers published with long term follow-up. The Revision Stem has been used in more than 25,000 surgeries to date. Most recently, LimaCorporate introduced the Revision Stem odd sizes, enlarging applicability criteria, and improved the Instrument Set layout reflecting the company's ongoing commitment to deliver innovative, powerful, and robust solutions to Orthopaedic surgeons. "The excellence of the Italian innovation and technology, combined with the great contribution coming from Orthopaedic surgeons are summarized in our Hip Revision portfolio. LimaCorporate is reconfirming its role in the Orthopaedic market with a special passion for complex cases, becoming the preferred choice for the experts in this field as our 3D Printed technology allows surgeons to address their patients' needs with a new outlook, including that of custom devices from our ProMade division," said Luigi Ferrari, CEO of LimaCorporate. About LimaCorporate LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate's product range includes large joint revision and primary implants and complete extremities solutions including fixation. For additional information on the Company, please visit: https://limacorporate.com/ . SOURCE Limacorporate S.p.A.

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30 May

Titan Spine ‘turns it to eleven’

May 28, 2018 - by  / BizTimes Milwaukee Business News

With a proprietary surface technology and a runway of private equity investment, Titan Spine LLC has, to borrow a phrase from the cult classic film “This is Spinal Tap,” turned its growth up to 11.

The Mequon-based medical device developer was established after surgeon Dr. Peter Ullrich came up with the idea to make interbody spinal implants out of titanium instead of plastic to better encourage bone growth.

It turns out, he was on to something.

Titan Spine launched in 2006 and has since created a sea change in its industry vertical. Over the past 10 years, it has grown at a rate of more than 40 percent per year. More than 70,000 of its devices have been implanted, it has more than 50 patents and the company has grown to $63 million in revenue. Titan Spine recently raised $15 million in a private equity round.

Early days

In 2002, when he was working as a spine surgeon in Neenah, Ullrich was seeking a medical device that wouldn’t damage a portion of the spine called the end plate in an interbody fusion procedure, but there wasn’t one. He had identified a problem.

“We were doing threaded cages. They were titanium cages but they were round,” Ullrich said.

“Structurally, it didn’t make a lot of sense to me and the cages would tend to do something called subside, which the cage would work its way into the bone.”

He came up with a new design by changing the dimensions of the cage and providing a surface to keep the cage in that didn’t damage the end plate.

So Ullrich contacted his friend at spine and orthopedic biosurgery company Orthovita Inc. (now part of Stryker Corp.) to develop the device, Endoskeleton TA. By 2004, the Endoskeleton had received FDA clearance for use as a vertebral body replacement and Ullrich was using it in patients.

But Ullrich’s product didn’t receive FDA approval at Orthovita as an interbody fusion device.

Ullrich decided to form a new company around his invention, which bought back the business from Orthovita, and Titan Spine was born. He brought on friend Kevin Gemas to manage the business side and Steve Cichy to focus on sales. Ullrich, now chief executive officer, and Gemas went to high school together in Plymouth.

“We became best friends and he went into surgery, I went into football and business, and then we came back together on this idea,” said Gemas, now president of Titan Spine.

Gemas previously owned KWG & Associates Inc., and founded and served as president of College Bound Student Athletes.

The pair started Titan Spine out of an apartment in Sheboygan Falls, putting in their own money, raising money from friends and family, and growing the business organically, investing any profits back into the business for eight or nine years.

While most spinal implants on the market were made of plastic, the Endoskeleton was made of titanium.

“We were like the rebels. Very few people had titanium and we were one of the only ones that (used) titanium and we kept preaching our surface technology years earlier,” Gemas said.

Surgeons were used to inserting a plastic implant, then surrounding it with biologic material, such as a bone graft, that would encourage bone growth at the site. But Titan Spine contends the biologics, which can be expensive, are not needed because the proprietary grooved nanoLOCK surface on the devices it has developed is a strong enough encouragement for bone growth.

“We wanted to make a device that participated in the fusion process instead of just being a spacer,” Gemas said.

With its nanoLOCK products, Titan has been able to reduce the amount of time patients are taking opioids and shorten the recovery time, Ullrich said.

  READ THE REST HERE  

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30 May

International Stem Cell Corporation Published Technology for Cartilage Generation in Journal of Tissue Engineering and Regenerative Medicine Technology

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. To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0 To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell 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

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30 May

K2M Receives FDA Clearance for BACS® Patient-Specific Module

LEESBURG, Va., May 30, 2018 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (NASDAQ:KTWO) (the "Company" or "K2M"), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for BACS® Patient-Specific devices. With the BACS Surgical Planner, surgeons can create pre-contoured rods, rails, and templates that match the surgeon’s preoperative plan. This is K2M’s fifth module within the BACS platform, and its first clearance for patient-specific devices.

“Templated, pre-contoured rods have made a big difference to my practice,” said Carmen Petraglia, MD, spine surgeon at South Hills Orthopaedic Surgery Associates in Pittsburgh. “Pre-contoured rods take out a huge question factor in terms of time. With pre-contoured rods, you save time by not having to contour your rods during surgery.” K2M manufactures BACS Patient-Specific Rods and Rails using a machine rolling method, replacing the manual three-point bending method that often reduces rod fatigue strength. By incorporating data from BACS Surgical Planner, rods and rails can be manufactured with complex multi-contoured designs. BACS Patient-Specific Rods and Rails can be used with the MESA®, EVEREST®, and DENALI®Spinal Systems. “Personalized solutions for treating spinal deformity is a positive development for patients who may benefit from having surgery tailored to their unique needs,” said K2M Chairman, President, and CEO Eric Major. “K2M is excited to realize this vision, as evidenced by our first regulatory clearance for BACS Patient-Specific devices. When coupled with our BACS Surgical Planner, K2M is well-positioned to become an industry leader in creating patient-specific devices, with an ultimate goal of facilitating 3D spinal balance and improved quality of life.” K2M’s BACS Surgical Planner provides surgeons with a comprehensive tool to preoperatively measure and record a patient’s skeletal parameters to obtain baseline measurements that aid in the creation of BACS Patient-Specific Rods. BACS Surgical Planner is part of K2M’s Balance ACS® (or BACS) platform, which provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach in the axial, coronal, and sagittal planes, emphasizing Total Body Balance as an important component of surgical success. For more information about K2M’s complete product portfolio, visit www.K2M.com. For more information on Balance ACS, visit www.BACS.com. About K2M K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on FacebookTwitterInstagramLinkedIn and YouTube. Forward-Looking Statements This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons and hospital customers the merits of our products and to retain their use of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to maintain adequate working relationships with healthcare professionals; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems or those of our suppliers, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to remediate the material weaknesses in our IT general controls; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects associated with the exit of the United Kingdom from the European Union; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of a fiscal year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility; worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC. We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements. The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make. Media Contact: Zeno Group on behalf of K2M Group Holdings, Inc. Christian Emering, 212-299-8985 Christian.Emering@ZenoGroup.com Investor Contact: Westwicke Partners on behalf of K2M Group Holdings, Inc. Mike Piccinino, CFA, 443-213-0500 K2M@westwicke.com

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29 May

CASE STUDY: One hospital’s quest to drive down the pricing of total joints

Getting the price right: Hospitals target variation in joint replacement (by Maria Castellucci for ModernHealth)

When HonorHealth leaders were looking for ways last year to decrease spending, the joint-replacement service line stuck out as a big opportunity. The procedures are one of the Scottsdale, Ariz.-based system’s most popular—and lucrative—service lines and make up a significant percentage of supply chain costs, which account for nearly 40% of its $1.7 billion in revenue, according to 2016 financial data from Ernst & Young. But HonorHealth was paying more for parts than its competitors. “If you haven’t been focused on the cost of your implants and the cost of your supplies, you get a natural creep up—we were simply paying too much. The prices we were paying exceeded what we believe is the market price,” said Alice Pope, chief financial officer at HonorHealth, which operates five hospitals in Phoenix and Scottsdale. The system worked with Premier, the large group purchasing organization and consultancy, to figure out how its approximately 15 implant vendors compared to each other in costs. They found a lot of variability.
Costs were “anywhere from 10% to 20% higher than we should’ve been at price point,” said Timothy Miller, vice president of procurement and supply chain at HonorHealth. He added that eight of the vendors accounted for 80% of total implant costs, which are about $20 million. Over several months, HonorHealth leaders worked with surgeons and vendors to negotiate better prices on implants. That effort was successful, to the tune of $1.5 million in annual savings. HonorHealth is typical of providers nationwide that see joint-replacement surgery—usually a secure money-making machine for hospitals—as a prime opportunity to generate savings, especially as they face shrinking margins with declining reimbursement and patient volumes. Tackling the wide variability in costs for joint-replacement surgery is a way to get ahead financially. More than 1 million joint replacements are performed every year in the U.S., and by 2030 that number is expected to increase to more than 4 million as the number of senior citizens grows. “Hospitals are looking for where they can trim. Supply costs are the largest costs, except labor, for a health system. People would much rather cut supply than cut someone’s job, period,” said Rob Austin, a director at Navigant. And the largest portion of costs for joint-replacement procedures are supplies, specifically implants, according to a recent analysis from Premier. There is also significant variation in the cost of those expensive implants. Premier found that among 350 hospitals, the average cost of primary knee implants was $4,464. Yet 50% of the hospitals paid between $4,066 and $5,609 on the devices. The same group of hospitals paid an average of $5,252 for primary hip implants, with 50% paying between $4,759 and $6,463. joint replacement surgeries According to Premier, the 350 hospitals could save $23.7 million on knee implants and $19.1 million on hip implants if they paid the same amount as the top 25th percentile of hospitals. The cost data came from Premier’s database of 1,100 hospitals. But convincing surgeons to switch the vendors and devices they are used to isn’t always an easy sell.
  READ THE REST HERE   see HonorHealth Orthopedics Website here

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25 May

OrthoAtlanta Surgeons Participate in Atlanta-Based Orthopedic Medical Mission to Honduras Providing Total Knee Replacements

ATLANTAMay 25, 2018 /PRNewswire/ -- OrthoAtlanta orthopedic surgeons Michael J. Behr, M.D., and Peter J. Symbas, M.D., are two sports medicine physicians who have dedicated their careers to serving others, treating Atlanta-area patients with the most complex sports injuries, including those in need of total joint repair and joint replacement surgeries. These dedicated medical professionals are also known for generous donation of their time and talents to those in need in some of the most impoverished parts of the world. Dr. Behr and Dr. Symbas recently returned from a week-long medical mission trip in Honduras where their total joint replacement expertise contributed to a first-of-its-kind orthopedic surgical effort at Holy Family Surgery Center in May 2018. As part of a brigade of 37 volunteer medical professionals specially trained in orthopedic surgery and surgical support, the Georgia-based team, including five orthopedic surgeons, surgical nurses and medical specialists, completed thirty-seven (37) total knee replacement surgeries in three days. This number was nearly one-third the total number of knee replacements performed the previous year throughout the entire country. The remarkable Atlanta-based team traveled to Honduras as part of One World Surgery, a non-profit organization that founded and runs Holy Family Surgery Center in Honduras. Approximately one hour northeast of Tegucigalpa, the capital of Honduras, the surgery center is located on the property of Nuestros Pequeños Hermanos (NPH), a 2,000-acre ranch that serves as a loving home for some 500 orphaned, abandoned and disadvantaged children in Honduras. Providing educational and technical training for the youth, it's a testament to the organization's mission of sustainability and giving back that nearly half of the surgery center staff were NPH residents at one time. Surgeries at the center are needs-based and provided to pre-qualified patients of all ages. Supplementing the services of this surgery center, One World Surgery coordinates brigades of volunteer medical experts for week-long service. Prior brigades have included heart surgery, OB/GYN and ophthalmology. Although orthopedic specialists have served the organization in the past, the Atlanta-based team, who have coined the name OneJoint, enabled the first-ever focused effort on total knee replacement specifically. Preparation for the Georgia-based orthopedics team endeavor was many months in the planning. Crosslink Orthopedics, a local medical equipment supply company based in Norcross, Georgia, donated all the medical hardware for the joint replacements. Thomas Fleetwood from Crosslink reached out to orthopedic surgeons from several of Georgia's leading orthopedic and sports medicine practices, including Dr. Symbas and Dr. Behr of OrthoAtlanta. Additional team members included skilled OR and post-operative nurses and medical technicians bringing the entire operating brigade to 37 people. The trip was entirely self-funded, from initial registration fees and flights to extra baggage fees needed for some 20 crates of equipment and supplies. A practicing orthopedic surgeon with OrthoAtlanta for over 25 years, Michael J. Behr, M.D., has served on other medical mission trips in the past, including an Atlanta-based orthopedic group serving the country of Haiti. Dr. Behr's first trip to Haiti was in 2010, the year of the deadly earthquake that killed thousands of people and left so much of the island in ruins. Inspired by the people of Haiti and the medical needs that continue today, Dr. Behr recently completed his ninth trip to Haiti in February 2018. Dr. Behr, who today serves as the OrthoAtlanta medical director, shared insights into his draw to Haiti, and now Honduras. Dr. Behr said, "Impoverishment in Latin America, Central and South America is real and there is an ongoing need for quality medical care. The ability to return an individual in Honduras to a highly functional level with a 'new knee' does more than improve one individual's quality of life - it affects the whole family and often an entire community." Peter J. Symbas, M.D., an OrthoAtlanta orthopedic surgeon with subspecialty certification in sports medicine, has also served on other medical mission trips, including a trip to Haiti in 2017. When asked why he goes on mission trips, Dr. Symbas commented, "I get so much more out of these trips than even the many people whose lives we touch. Nothing is more rewarding than the smiles we receive in return." Dr. Symbas, who sees patients at OrthoAtlanta offices including Piedmont West, Kennesaw and Marietta, also serves as the chief medical officer for Atlanta United FC, Atlanta'sprofessional soccer team and is the chief of orthopedics for the Piedmont Clinic for Piedmont Healthcare. The Atlanta-based team of orthopedics professionals who recently returned from a week's accomplishments in Honduras is committed to returning to the country in 2019 as part of a sustained, long-term effort to provide orthopedic service to the Honduran people. Watch for future information about their upcoming commitment to service. About OrthoAtlanta OrthoAtlanta is one of the largest physician-owned orthopedic and sports medicine practices in the greater Atlanta, Georgia, area providing an integrated approach to delivering musculoskeletal care. With 38 physicians serving in 14 offices, the practice provides the highest level of patient care for injury or deformity of muscles, joints, bones and spine. OrthoAtlanta offers convenient accessibility to a full range of musculoskeletal surgeons, specialists and patient services including on-site physical therapy, pain management care, seven MRI imaging centers and workers' compensation coordination. OrthoAtlanta Surgery Centers in Austell and Fayetteville provide cost-effective, same-day surgical procedures in an accredited outpatient center. Comprehensive operative and non-operative musculoskeletal care and expertise includes sports medicine, arthroscopic surgery, hip replacement, knee replacement, neck and spine surgery, elbow and shoulder surgery, hand and wrist surgery, foot and ankle surgery, physical medicine and rehabilitation, arthritis treatment, general orthopedics, work-related injuries and acute orthopedic urgent care. Learn more at www.OrthoAtlanta.com. For additional information, please contact Pat Prosser, Public Relations Manager, at OrthoAtlanta, 678-996-7254, or via email pprosser@OrthoAtlanta.com.

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