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October 30, 2018 OrthoSpineNews

COLUMBIA, Md., Oct. 30, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, will present advanced clinical and scientific research at the Symposium on Advanced Wound Care (SAWC) Fall Conference. A total of six studies (three clinical and three scientific studies) will be presented.

The clinical studies highlight the benefits of Osiris’s placenta-based products, Stravix®, Grafix® and GrafixPL®, for use in covering a variety of wound types. The scientific studies describe methods of cell viability evaluation in placental tissue and the structure and properties of tissues preserved using Osiris’s Prestige Lyotechnologysm, which retain all components of the native tissue including living cells but can be conveniently stored at ambient temperature.  Key presentations and events are highlighted below.

Dr. Eric Johnson, MD, will present a lecture entitled “Scientific and Clinical Evidence for Grafix and GrafixPL: Cryopreserved and Lyopreserved Placental Membranes” on Friday, November 2, at 7:30am (Milano V-VI Ballroom, onsite registration available). Lecture objectives include:

  • Information on how placental membranes benefit wound management
  • An overview of how different tissue preservation methods impact the final composition of placental membrane products
  • An introduction to Prestige Lyotechnology for ambient storage of placental membranes
  • Clinical evidence for wound management with Grafix and GrafixPL

Dr. Charles E. Ananian, DPM, will present a poster summarizing results of a recently completed multicenter, prospective, randomized, single-blind trial comparing clinical outcomes and product cost between Grafix and Dermagraft®(1) in the treatment of chronic diabetic foot ulcers (DFUs)(2).

Dr. Alexander Reyzelman, DPM, FAPWCA, will present a poster describing the first prospective cases series evaluating clinical outcomes of GrafixPL, Osiris’s lyopreserved placental membrane, for the management of chronic wounds of various etiologies. This study demonstrates similar closure rates to previous studies utilizing Grafix, Osiris’s cryopreserved placental membrane, but with convenience of ambient storage.

Dr. Kathryn Davis, PhD, and Dr. Lawrence Lavery, DPM, MPH, will present a poster comparing amnion lyophilized by the Prestige Lyotechnology method (PL) to cryopreserved amnion. Data shows that the structure and cell viability of PL-lyophilized amnion is equivalent to those of cryopreserved viable amnion.

Scientific and clinical posters will be presented at the SAWC fall poster reception from 5:30 pm to 6:15 pm on Saturday, November 3 in the Forum Ballroom, Room 12.

The complete list of scientific and clinical abstracts includes:

  • A Multicenter, Randomized, Single-Blind Trial Comparing the Efficacy of Viable Cryopreserved Placental Membrane to Human Fibroblast-Derived Dermal Substitute for the Treatment of Chronic Diabetic Foot Ulcers (Abstract CR-001)
  • A Prospective, Single-Center, Open-Label Case Series Evaluating the Clinical Outcomes of Viable Lyopreserved Placental Membrane in the Treatment of Chronic Wounds (Abstract CS-063)
  • Contralateral Limb Salvage in a Diabetic Amputee with Necrotizing Fasciitis: A Case Report Supporting the Use of Viable Cryopreserved Umbilical Tissue to Prevent Bilateral Amputation (Abstract CS-080)
  • Structure and Cell Viability of Lyophilized Amniotic Membrane are Equivalent to Those of Cryopreserved Viable Amnion (Abstract LB-009)
  • Structural Properties of Viable Lyophilized Placental Tissues (Abstract LB-020)
  • Assessment of Human Amniotic Tissue Cell Viability (Abstract LB-028)

Osiris Therapeutics, Inc. will also be exhibiting at the Symposium on Advanced Wound Care Fall Meeting at booth 321. The event runs from November 2 through November 4, 2018 at Caesars Palace in Las Vegas, Nevada.

References:
1-Dermagraft® is a registered trademark of Organogenesis, Inc. (Canton, MA)
2-www.clinicaltrials.gov: NCT02675855

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs.  We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO and Cartiform®.  We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products.  Osiris®, Grafix®, GrafixPL®, GrafixPL PRIME Cartiform®, and Prestige Lyotechnologysm are our trademarks. BIO is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

Statements herein relating to the future of Osiris Therapeutics, Inc. and the ongoing research and development of our products are forward-looking statements.  Osiris Therapeutics, Inc. cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements.  These risks and uncertainties include those identified under the heading “Risk Factors” in the Osiris Therapeutics Inc. Annual Report on Form 10-K for the years ended December 31, 2017, 2016 and 2015 and Quarterly Report on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018, as filed with the Securities and Exchange Commission (SEC).  We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.  Examples of forward-looking statements may include, without limitation, statements regarding the anticipated efficiencies and advantages of products and the likelihood of customer clinical adoption of any new products.  Although well characterized in scientific literature and studies, preservation of tissue integrity, including cells, may not be indicative of clinical outcome.  Accordingly, you should not unduly rely on these forward-looking statements. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties.  The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.  Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For additional information, please contact:
Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com


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October 25, 2018 OrthoSpineNews

SAN DIEGO, Oct. 24, 2018 (GLOBE NEWSWIRE) — Samumed announced today top-line data from its phase 2b trial of SM04690 in knee osteoarthritis (OA). Results showed that treatment with a single intra-articular injection of SM04690 demonstrated significant improvements in pain, function and patient global scores in two separate doses. Further details can be found here.

Samumed’s phase 2b trial was a 700-patient, 24-week, multi-center, randomized, double-blind, placebo-controlled study of four concentrations of SM04690, a Wnt pathway inhibitor, injected once intra-articularly into the target knee joint of subjects with moderately to severely symptomatic knee OA. Details of the study can be found here.

“The safety profile, the improvements in signs and symptoms, and the disease-modifying benefits of SM04690 that we have observed in this phase 2b as well as earlier studies, are quite promising,” said Osman Kibar, CEO of Samumed. “We look forward to working with the FDA to take SM04690 into phase 3 pivotal trials, targeting a start date in early 2019.”

About SM04690 and Osteoarthritis
SM04690 is a small molecule inhibitor of the Wnt pathway administered as an intra-articular injection and is being developed as a potential disease-modifying drug for osteoarthritis (DMOAD). SM04690’s mechanism of action exhibits three separate effects on joint health – generation of cartilage, slowing down of cartilage breakdown, and reduction of inflammation. There are currently no approved disease-modifying treatments for osteoarthritis. Additional information on Samumed’s SM04690 osteoarthritis program can be found here: https://www.samumed.com/pipeline/detail.aspx?id=20

About Samumed 
Samumed’s small-molecule drug platform is harnessing the innate restorative power of the Wnt pathway to reverse the course of severe and prevalent diseases. Learn more about Samumed’s potential regenerative drug candidates and broad clinical pipeline at https://www.samumed.com/pipeline/default.aspx

Corporate Contact:
Erich Horsley
Samumed, LLC
erich@samumed.com
858-365-0200

Investor Contact:
Ashley Robinson
LifeSci Advisors
arr@lifesciadvisors.com
617-535-7742

Media Contact:
Josephine Belluardo, Ph.D.
LifeSci Public Relations
jo@lifescipublicrelations.com
646-751-4361


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October 25, 2018 OrthoSpineNews

October 25, 2018

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus, a global leader in orthobiologic solutions, today announced the appointment of Susan M. Stalnecker, former Vice President and Treasurer, E.I. du Pont de Nemours and Company, to the company’s Board of Managers, replacing Michael Minogue.

“Susan is joining the Bioventus Board at an exciting time as we accelerate the growth of our osteoarthritis business, expand our surgical orthobiologics business and continue to launch our products in new international markets like Brazil,” said Tony Bihl, CEO of Bioventus. “Her global financial background, experience leading audit and finance committees and leadership roles on both public company and nonprofit boards will provide us with fresh perspectives and insights to help drive our strategy to be a global leader in orthobiologics.”

“The orthobiologic space intrigues me and I believe I can help the team at Bioventus achieve their goals of bringing more solutions to market to help patients heal and return to active lifestyles,” said Stalnecker. “Clinicians and spine surgeons around the world are noticing this company and its innovations, and I am eager to guide Bioventus as it continues to grow into these markets.”

Stalnecker served as Vice President of E. I. du Pont de Nemours and Company until she retired in 2016. During her nearly 40-year career at DuPont she served in several senior leadership roles including Vice President, Treasurer & M&A Vice President, Risk Management; Vice President-Government and Consumer Markets; and, Vice President Productivity & Shared Services.

Stalnecker served on the Board of trustees of Duke University from 2003 to 2015, and as Vice Chair from 2003-2005. She currently serves on the Board of Directors of Leidos Holdings, Inc., Board of Trustees, Optimum Fund Trust and the Board of Trustees, Duke Health System. In addition, she was a Board Director of PPL Corporation. She is also a Senior Adviser, Boston Consulting Group.

She received a bachelor’s degree from Duke University and an MBA from the Wharton School of Graduate Business at the University of Pennsylvania.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The orthobiologic products from Bioventus include offerings for osteoarthritis, surgical and non-surgical bone healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com


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October 24, 2018 OrthoSpineNews

October 24, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK) (“Anika” or the “Company”), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, announced that, effective immediately, Anika’s Board of Directors has appointed Susan Vogt as an independent director.

Ms. Vogt most recently served as Chief Executive Officer and Director of Aushon Biosystems, a venture-backed company with a novel multiplex immunoassay platform. She previously served as President, CEO, and a Director of SeraCare Life Sciences, a publicly traded life sciences company focused on human diagnostics and therapeutics. From 2001 to 2005, she served as President of the Biopharmaceutical Division of Millipore Corporation (now MilliporeSigma), where she began her career in 1981. She earned a Master of Business Administration with high honors in Finance from Boston University, where she received a Distinguished Alumni Award in 2009, and a Bachelor of Arts degree from Brown University.

The Company also announced that Steven Wheeler, who has served as a director of Anika since 1993 and currently chairs the Board’s Governance and Nominating Committee, has notified the Board of his intention to retire as of February 8, 2019.

“This is another important step in the transition of Anika’s leadership that began with the appointment of Joseph Darling as CEO in March of this year,” said Joseph L. Bower, Chairman of the Board of Directors, “and it demonstrates our continued commitment to strong corporate governance and refreshment of the Board.”

“Sue brings to Anika more than thirty-five years of experience in the global life science research, pharmaceutical, biotech and clinical diagnostics industries, and we are excited she is joining our Board,” said Joseph G. Darling, President and CEO of Anika. “We are confident that Anika will benefit greatly from her input and guidance as we continue to advance our ongoing initiatives and enhance our global commercial reach.”

“Anika has a strong foundation with a deep pipeline and a diverse commercial portfolio, and I am excited to work with the other directors and management team to continue advancing the Company’s important work. I look forward to leveraging my experience as we continue to advance Anika’s clinical programs, deliver important therapeutic options for patients and drive profitable growth to enhance value for Anika shareholders,” Ms. Vogt said.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) 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 hyaluronic acid (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.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications, Inc.
Sonal Vasudev, 917-523-1418
sonal@w2ogroup.com


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October 23, 2018 OrthoSpineNews

October 23, 2018

PRINCETON, N.J. & OR AKIVA, Israel–(BUSINESS WIRE)–Regentis Biomaterials today announced it has expanded the SAGE clinical trial of GelrinC™ for the treatment of articular cartilage damage in the knee to 11 U.S. sites. GelrinC is an investigational device being evaluated as a treatment to help the body regrow cartilage in the knee.

Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Damage to the cartilage layer can be extremely painful for patients and is generally associated with sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care is called microfracture, which involves drilling small holes in the underlying bone to allow a blood clot to form within the defect. However, microfracture often provides only short-term relief and may require repeat surgeries.

“Cartilage repair is the largest unmet need in orthopedic sports medicine today,” said Alastair Clemow, Ph.D., president and CEO, Regentis Biomaterials. “GelrinC enables patients to harness the benefits of their own stem cells to promote cartilage regeneration in a single, minimally invasive procedure.”

People with knee pain caused by damaged articular cartilage who would like to be considered for the study can inquire by visiting www.MyKneeStudy.com or by calling (833) 430-8686.

The following orthopedic centers are currently or will soon be recruiting patients, with additional sites to be added soon in Denver, Colorado; San Francisco, California; Orlando, Florida; and Portland, Oregon.

  • RUSH University Medical Center (Chicago, Illinois)
  • Fort Lauderdale Orthopaedic Surgery & Sports Medicine (Fort Lauderdale, Florida)
  • Grossmont Orthopaedic Medical Group (San Diego, California)
  • Peninsula Orthopaedic Associates (Salisbury, Maryland)
  • Andrews Research & Education Foundation (Gulf Breeze, Florida)
  • Mansfield Orthopaedics (Morrisville, Vermont)
  • University Orthopedics Center (Altoona and State College, Pennsylvania)
  • TRIA Orthopaedic Center (Minneapolis, Minnesota)
  • The San Antonio Orthopaedics Group (San Antonio, Texas)
  • Optim Orthopedics (Savannah, Georgia)
  • Alpine Orthopedics (Bozeman, Montana)

About the SAGE Clinical Trial

The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. The multi-center Phase III pivotal study will enroll 120 patients. All patients who meet study requirements and agree to enter the trial are provided GelrinC as treatment, and their results will be compared to raw level historical data of a microfracture control arm. To be eligible for the study, participants must be between the ages of 18 and 50 and have pain caused by cartilage damage in only one knee. To learn more about the SAGE study, please visit www.GelrinC.com or call (833) 430-8686.

About GelrinC™

In the U.S., GelrinC™ from Regentis Biomaterials is an investigational device for patients with articular cartilage damage in their knee. GelrinC is composed of a synthetic material called polyethylene glycol (PEG) and a structurally modified form of human fibrinogen, a protein which in its native form assists healing processes. PEG and native human fibrinogen have been used individually in medical products for many years with excellent results. GelrinC’s unique mode of action relies upon its ability to be implanted as a liquid so that it completely fills the defect, and then be cured into a gel that enables the body’s own stem cells to settle on its surface. Over a period of six to 12 months, the GelrinC is gradually resorbed by the body and replaced by new cartilage tissue. Preliminary clinical trials in Europe have indicated that this regenerated tissue provides excellent improvement in pain and function. To learn more about GelrinC, please visit www.GelrinC.com.

About Regentis Biomaterials

With offices in Princeton, New Jersey, and Or Akiva, Israel, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The technology was originally developed at the Technion-Israel Institute of Technology by Dr. Dror Seliktar. For more information, please visit www.regentis.co.il.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez
323.532.0746
joni@merrymancommunications.com


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October 22, 2018 OrthoSpineNews

Lund, Sweden, 08:00 CET, 22 October 2018 –BONESUPPORT, an emerging leader in orthobiologics for the management of bone voids, announces that it has started selling CERAMENT® BVF direct via its own US distributor network.

Emil Billbäck, BONESUPPORT’s CEO said “The launch of our own US distribution network is a key strategic milestone as we work towards our goal of becoming a global orthobiologics leader focused on the treatment of bone voids. Gaining control of our destiny in the US delivers multiple significant benefits that we are confident will allow us to build a much stronger BONESUPPORT business and deliver significant value to all of our stakeholders.”

BONESUPPORT created its own network of highly motivated distributors and expanded its US commercial organization to:

  •   Access a much larger market opportunity for CERAMENT BVF
  •  Increase its ability to drive end-user sales
  •  Deliver higher net margins
  •  Expand its US product offering
  •  Raise brand awareness ahead of the CERAMENT G launch

BONESUPPORT ‘s US network currently consists of 25 high quality distributors, that cover all key areas of the US bone void filler market that the Company is targeting. Together these distributors employ a total of 512 sales reps.

  • their close relationships to the leading orthopedic surgeons in their region,
  •  a track record of sales success, and
  •  dynamic sales reps who spend significant time in the operating theatre with the surgeons who are the key target customers for CERAMENT BVF

BONESUPPORT’S own US commercial organization of 21 employees is, in parallel, approaching key national purchasing organizations to ensure that CERAMENT BVF will have access to a growing number of hospitals.

This strengthened US commercial platform will launch new products from its recent agreements with Collagen Matrix Inc. and MTF Biologics, which are complementary to CERAMENT BVF, in the first half of 2019.

Patrick O’Donnell, General Manager & Executive Vice President of Commercial Operations North America, said “We are extremely pleased with the strength and reach of the US network of independent distributors that we now have in place. Their highly motivated reps will start selling CERAMENT BVF today targeting orthopedic surgeons, focused on trauma, total joint arthroplasty, foot & ankle, and orthopedic oncology. I am very confident that our new enlarged commercial platform will drive significant US sales growth in 2019 and beyond.”

BONESUPPORT terminated its exclusive distribution agreement for CERAMENT BVF with Zimmer Biomet (ZB) for the US market in May 2018. Under the terms of this agreement, ZB’s exclusivity expired on 20 October 2018. ZB will continue to be a non-exclusive distributor of CERAMENT BVF until 21 April 2019. 

For more information contact:

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

David Dible, Shabnam Bashir, Pip Batty

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About BONESUPPORT™

 BONESUPPORT is an innovative commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology and foot and ankle.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

BONESUPPORT is currently conducting two important clinical trials to generate data demonstrating the clinical and health economic benefits its products deliver. The first trial, CERTiFy, is comparing CERAMENT BVF with autograft, the most widely used approach for managing bone voids. Top line results from this study are due to be announced at the end of 2018. The FORTIFY study is assessing CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and a reduction in the number of secondary procedures intended to promote fracture union. Data from this study will be used for a planned Premarket approval filing with FDA in 2020.

The Company’s research and development is focused on extending the use of its CERAMENT technology into further indications via the incorporation of additional drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

BONESUPPORT is also preparing to expand its product offering in the US and has entered into strategic agreements with Collagen Matrix Inc. and MTF Biologics to gain access to products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.

CERAMENT V: Not available in the United States.

BONESUPPORT® and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on 22 October 2018.


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October 18, 2018 OrthoSpineNews

SCHLIEREN (ZURICH), Switzerland, Oct. 18, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences AG (SIX: KURN) announced today that the Company has reached a key milestone in its Fibrin-PTH (KUR-113) spinal fusion product candidate development program with the submission of a 510(k) regulatory package for its enabling lumbar intervertebral body fusion device to the U.S. Food and Drug Administration (FDA).

Kuros Biosciences will include this news in its program update to the North American Association of Spinal Surgeons (NASS) orthobiologics course ‘2018 Biologic Interventions for Spinal Pathologies: Stem Cells, Growth Factors & Novel Therapeutics’ being held in Chicago on Friday October 19.

“The submission of this US FDA 510(k) regulatory package keeps our KUR-113 spinal fusion product candidate development on track. Completion of the lumbar intervertebral body fusion device development is an important corporate milestone as the device will be used in the upcoming clinical trials in combination with Kuros’ spinal fusion product candidate KUR-113,” said Joost de Bruijn, CEO of Kuros.  “Coupled with the invitation to present an update at such a highly focused spine meeting of acknowledged experts in orthobiologics science marks the successful progress of our Company.”

About KUR-113
KUR-113 consists of a natural fibrin-based healing matrix with an immobilized targeted bone growth factor (truncated human parathyroid hormone (PTH) analog). KUR-113 is designed to be applied directly into and around an intervertebral body fusion device as a gel, where it polymerizes in situ. KUR-113 will be combined with the interbody spacer device in the upcoming clinical trial for interbody spinal fusion.

About the NASS ‘2018 Biologic Interventions for Spinal Pathologies’ Meeting
The field of spinal biologics is rapidly evolving as patients, researchers, and clinicians are recognizing its potential to treat challenging painful conditions. While the roles of both nonoperative and surgical treatment are relatively well-defined in the spine care treatment landscape, the indications, risks, and concerns regarding biologics for a variety of spinal conditions have not been agreed upon. Because of the differences in regulatory pathways for many of these products, the availability of data is variable making administrative decision-making difficult. This meeting will bring together exciting minds from academia and industry to discuss pertinent technologies and relevant issues in biologics use for spinal conditions.

For further information, please contact:
Kuros Biosciences AG Media & Investors
Michael Grau Hans Herklots
Chief Financial Officer LifeSci Advisors
Tel +41 44 733 47 47 +41 79 598 7149

About Kuros Biosciences AG 
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kurosbio.com for additional information on Kuros, its 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.


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October 17, 2018 OrthoSpineNews

Gosselies, Belgium, 17 October 2018, 6 pm CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces results of the first efficacy study of the Company’s enhanced viscosupplement, JTA-004, in patients with moderate symptomatic knee osteoarthritis, supporting future clinical development of the product.

JTA-004 is a patented, non-cellular viscosupplement product for the treatment of knee osteoarthritis (KOA), which Bone Therapeutics has been developing in parallel with its core cell therapy pipeline and addressing its mission of bringing innovative solutions to orthopaedic conditions.

The Company believes the favourable safety and efficacy profile of JTA-004 observed in this first efficacy study supports the move to registration studies and will begin dialogue with the regulatory authorities to determine next steps.

About the trial

The trial was a prospective, multicentre, randomised, double-blind, controlled study including three JTA-004 strengths and one reference product, hylan G-F 20, the global market leader in viscosupplements(1). The main objective of the study was to demonstrate the superiority of a single intra-articular JTA-004 injection to the reference product.

164 patients were randomly assigned to the reference group or one of the three JTA-004 groups. The primary endpoint of the study was the mean change in WOMAC® VA 3.1 pain subscale score (ranging between 0 and 100 mm) between baseline and 6 months after treatment.

Trial results

The single intra-articular injection of JTA-004 was generally well tolerated. At six months, patients in the three JTA-004 groups showed an improvement in pain vs. baseline ranging from 23.6 mm to 25.9 mm, while patients in the reference group only showed a 14.3 mm improvement. Due to high variability in primary endpoint at six months, statistically significant differences between the individual JTA-004 groups and the reference group were not achieved.

Analysis of the results revealed that the three JTA-004 strengths had a similar efficacy. Therefore, a post hoc exploratory analysis was subsequently performed between the reference group and all pooled JTA-004 treated patients. The exploratory analysis showed a 26.1 mm improvement for the pooled JTA-004 group vs. 15.6 mm(2) for the reference group at month 6, demonstrating a statistically significant superiority of the pooled JTA-004 group compared to the leading viscosupplement on the market.

Professor Jean-Francois Kaux, Head of the department of Physical and Rehabilitation Medicine at University Hospital CHU, Liège, Belgium, commented: “Globally, millions of patients are suffering from knee osteoarthritis which is a leading cause of chronic pain and disability. The management of this condition represents a continuing challenge for clinicians and patients, who are seeking stronger and longer-lasting pain relief alternatives for this painful disease. The strong safety and efficacy profile demonstrated by JTA-004 in this clinical study, in comparison with the most scientifically validated reference product, suggests potential for it to become one of the preferred treatments for patients suffering from knee osteoarthritis. I look forward to the future development of this unique product.

Osteoarthritis is a progressive disease of the joints and is the most prevalent joint disorder globally. It is characterized by joint pain, tenderness, limitation of movement and stiffness. Knee osteoarthritis, the most common form, affects approximately 250 million people worldwide(3). The prevalence of KOA is expected to increase at a rate of 8% per year in the coming years due to increasingly aging and obese population. The worldwide sales of viscosupplements, one of the commonly used treatments for KOA, had an estimated value of $2.1B in 2016(1).

Viscosupplements are injectable solutions containing hyaluronic acid (HA), a main component of knee joint’s synovial fluid and aim to provide added lubrication and protection to the cartilage of the arthritic joint. JTA-004, which consists of hyaluronic acid, an analgesic and anti-inflammatory agent and an enriched protein solution, showed distinct advantages in preclinical studies over other viscosupplements due to its anti-inflammatory and lubrication properties.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, added: “We’re delighted with the data from this first trial of JTA-004 in patients with moderate symptomatic knee osteoarthritis, which shows the potential of this enhanced viscosupplement. Based on the favourable efficacy and safety profile observed in this trial, JTA-004 can offer advantages over currently available viscosupplements on the market and we plan to continue the development of this promising product. JTA-004 is a promising addition to our existing pipeline of bone cell therapy clinical programmes, and highly complementary to our broader goal of bringing to market innovative, best-in-class solutions to orthopaedic conditions and bone diseases.

Continued clinical and manufacturing progress

The positive JTA-004 data complement recent positive clinical and manufacturing developments at Bone Therapeutics which support the continued progress of its pipeline and the increased focus on preparing for commercialisation. Notable recent progress includes:

·In September, Bone Therapeutics announced a positive final readout in the Phase I/IIA delayed-union study of allogeneic bone cell therapy product, ALLOB, adding to a growing body of clinical efficacy and safety data.

·Also in September, the Company presented preclinical in vitro and in vivo results at the 26th Annual Meeting of the European Orthopaedic Research Society (EORS) in which the scientific community acknowledged the potent bone-forming properties of its allogeneic platform.

·Bone Therapeutics also recently announced an optimized production process for ALLOB which allows the Company to achieve a consistent, easy to scale up and economical (around 100,000 doses per donor) manufacturing process and to offer an easy to use, cryopreserved product, all critical parameters required for future commercialisation. The Company plans to implement this optimized process for all future clinical development programmes. Bone Therapeutics received positive feedback on the quality control programme and non-clinical strategy for ALLOB from a Regulatory Agency for the optimization of the manufacturing process.

·The Company’s focus over the next few years is on progressing the clinical development of ALLOB in delayed union fractures and lumbar spinal fusion, subsequently leading to Phase III clinical trials in EU and USA.

·In addition, Bone Therapeutics expects to present the conclusions of the interim analysis after a one-year follow-up of the Phase III study of PREOB, its autologous cell therapy product, in osteonecrosis of the hip in Q4 2018.

(1) Viscosupplementation: Global Analysis and Market Forecasts, April 2017, Global Data
(2) The difference in the mean improvement of the reference group at Month 6 between the two analyses was a consequence of the statistical adjustments for both sample size and sample variation.
(3) Vos et al., A systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163-96

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

The Company’s primary clinical focus is ALLOB, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. In addition, the Company also has an autologous bone cell therapy product, PREOB, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip, and JTA-004, a viscosupplement in development for the treatment of knee osteoarthritis.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About WOMAC® Index

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It can be self-administered and was developed at Western Ontario and McMaster Universities in 1982.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com

For Belgium Median Enquiries
Comfi
Laure-Eve Monfort and Sabine Leclercq
Tel: +32 (0)2 290 90 93, +32 (0)2 290 90 91
monfort@comfi.be, sabine.leclercq@comfi.be

International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


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October 11, 2018 OrthoSpineNews

HOUSTONOct. 11, 2018 /PRNewswire/ — SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts, today announced the publication of results from its study on using cell transplantation as a cell therapy for disc degeneration. The article titled “Therapeutic Effects of Cell Therapy with Neonatal Human Dermal Fibroblasts and Rabbit Dermal Fibroblasts on Disc Degeneration and Inflammation,” was published in The Spine Journal and is available at https://www.thespinejournalonline.com/article/S1529-9430(18)31093-3/fulltext.

The study found that transplanting dermal fibroblasts can significantly increase the markers of disc regeneration and supported the hypothesis that the intervertebral disc is immune privileged. Taken together with previous disc degeneration studies, this suggests that fibroblast cell therapies can prevent the degeneration and promote the regeneration of the spinal disc.

“Autologous and allogenic cell therapies for disc degeneration and back pain are feasible, well tolerated, and appear to have clinical efficacy,” said Howard An, M.D., The Morton International Endowed Chair Professor of Orthopedic Surgery, Director Spine Fellowship Program at Rush University Medical Center, and principal investigator of this study. “Human dermal fibroblasts continue to be found safe and well-tolerated in clinical studies while being both therapeutic and regenerative in diseases including disc degeneration.”

“Fibroblast cell therapy is a viable way to address the cause of disc degeneration rather than just treat symptoms,” said Pete O’Heeron, SpinalCyte Chief Executive Officer. “The results from this preclinical study validate our ongoing Phase 1/Phase 2 trials in the treatment of degenerative disc disease with CybroCell, where over 85% of patients using CybroCell report significant therapeutic improvement at 6 months.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell

CybroCell is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated preliminary six-month data whereby 83% of patients had an increase or no change in disc height.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal replacement using human dermal fibroblasts. Currently, SpinalCyte holds 33 U.S. and international issued patents and has filed for an additional 43 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.

Contact: 
David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SOURCE SpinalCyte, LLC

Related Links

http://www.spinalcyte.com


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October 2, 2018 OrthoSpineNews