DiscGenics Announces First Patient Treated in U.S. Clinical Trial of IDCT for Degenerative Disc Disease
SALT LAKE CITY, April 26, 2018 /PRNewswire/ -- DiscGenics, Inc., a clinical stage regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the first patient has been treated in its phase I/II U.S. clinical trial of IDCT for mild-to-moderate degenerative disc disease (DDD). The treatment took place at Carolina Neurosurgery and Spine Associates in Charlotte, NC, led by the study's principal investigator, Domagoj Coric, M.D. IDCT is an allogeneic (donor-derived), non-invasive cell therapy comprised of proprietary Discogenic Cells and a viscous scaffold carrier. This prospective, randomized, double-blinded, vehicle- and placebo-controlled study is designed to evaluate the safety and preliminary efficacy of IDCT at varying dosage levels in subjects with single-level, symptomatic lumbar DDD, a major cause of chronic low back pain. "We are thrilled to be participating in the clinical evaluation of this potentially game-changing therapy for patients with DDD," said Dr. Coric. "If the outcomes observed in human subjects are consistent with preclinical study findings of IDCT, which indicated reduced inflammation and disc height restoration, the result could be reduced pain and disability, offering a truly regenerative therapy for one of the most common causes of chronic low back pain." "Commencing clinical evaluation of our first product candidate is a critical milestone for DiscGenics as we continue to advance IDCT as a potentially revolutionary treatment for DDD," said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. "The millions of patients who suffer from low back pain every year currently have limited treatment options, one of which is opioid use for pain management. If proven effective, IDCT could be a vital tool for curtailing opioid addiction among those who suffer from this debilitating condition." The trial will take place in up to 10 centers across the U.S. and will enroll approximately 60 subjects. Those who meet all eligibility criteria will be randomized to one of four treatment cohorts: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and placebo (n=10). Each subject will receive a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc. Following treatment, subjects will be observed and evaluated for a period of one year, with a one-year extension period. For more information, please visit clinicaltrials.gov/. Initiation of this trial was supported by the U.S. Food and Drug Administration's (FDA) acceptance of the Company's investigational new drug (IND) application for IDCT, announced in the fourth quarter of 2017. DiscGenics is one of just two companies in the world with an allogeneic cell-based product for disc degeneration that is pursuing a Biologics License Application (BLA) from the FDA through its rigorous clinical and regulatory IND pathway. About DiscGenics DiscGenics is a privately held, clinical stage regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics is harnessing the restorative potential of cells native to the intervertebral disc to develop what we hope will be a profound therapeutic option for millions of patients suffering from the debilitating effects of back pain. DiscGenics' first product candidate, IDCT, is a homologous, allogeneic injectable cell therapy that utilizes proprietary Discogenic Cells to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate degenerative disc disease. SOURCE DiscGenics, Inc.
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April 30, 2018 LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the first quarter ended March 31, 2018. Net sales were $108.7 million, diluted earnings per share from continuing operations was $0.27 and adjusted earnings per share from continuing operations was $0.39. The Company also closed the acquisition of Spinal Kinetics Inc., a privately held developer and manufacturer of artificial cervical and lumbar discs. “Overall, we had another solid quarter in both top and bottom line performance, including a 290 basis point improvement in adjusted EBITDA margin and a 44% increase in adjusted earnings per share compared to the first quarter of 2017,” said Orthofix President and Chief Executive Officer, Brad Mason. “Since announcing our agreement to acquire Spinal Kinetics, we have received very positive feedback from physicians and our sales force about the M6® artificial discs and the strategic value this brings to Orthofix, which further validates our enthusiasm for this transaction. This deal delivers upon our stated strategy of accelerating top-line growth through the acquisition of products, technologies and companies in our core businesses. The Spinal Kinetics M6 artificial discs enters Orthofix into a fast-growing market with a proven technology and further demonstrates our commitment to providing innovative spine treatment solutions to surgeons and patients.” Financial Results Overview The following table provides net sales by strategic business unit (“SBU”):
|Three Months Ended March 31,|
|(Unaudited, U.S. Dollars, in thousands)||2018||2017||Change||Constant
|(Unaudited, U.S. Dollars, in millions, except per share data)||Low||High|
|Full Year 2018 Outlook|
|Net income from continuing operations||$||24.8||2||$||27.1||2|
|EPS from continuing operations||$||1.31||4||$||1.43||4|
|Adjusted EPS from continuing operations||$||1.58||5||$||1.68||5|
|2nd Quarter of 2018 Outlook|
|EPS from continuing operations||$||0.28||7||$||0.30||7|
|Adjusted EPS from continuing operations||$||0.35||8||$||0.37||8|
|1||Represents a year-over-year increase of 5.6% to 7.0% on a reported basis|
|2||Represents a year-over-year increase of 240.1% to 271.7%|
|3||Represents a year-over-year increase of 4.8% to 7.9%|
|4||Represents a year-over-year increase of 235.9% to 266.7%|
|5||Represents a year-over-year decrease of 2.5% to a year-over-year increase of 3.7%|
|6||Represents a year-over-year increase of 3.7% to 5.6% on a reported basis|
|7||Represents a year-over-year increase of 7.7% to 15.4%|
|8||Represents a year-over-year decrease of 11.9% to 16.7%|
Zimmer Biomet Partners with Faith In Practice to Improve Access to Musculoskeletal Care in Guatemala
WARSAW, Ind., April 30, 2018 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced today that it has entered into a partnership agreement with Faith In Practice, a Houston-based non-profit organization that provides surgical, medical, dental and educational programs in Guatemala. Under the partnership, Zimmer Biomet will donate instrument sets and provide implants for Faith In Practice to place in inventory with the goal of improving access to total knee arthroplasty procedures for patients in underserved communities. Through the partnership's model, Faith In Practice will utilize Zimmer Biomet implants at the Las Obras Hospital in Antigua and Hilario Galindo Hospital in San Felipe, Retalhuleu, Guatemala. "This is an outstanding partnership of two organizations that are focused on the health of those in need in developing countries such as Guatemala," said Brian S. Parsley, M.D., lead orthopaedic surgeon and member of Faith In Practice's board of directors. "Zimmer Biomet has been supportive of our medical mission work for many years, and this agreement will further our capacity to treat those patients in need and offer them an opportunity to walk comfortably, remain active and provide for their families. This partnership will allow our surgeons to reach out and help even more patients due to the availability of implants and equipment. Our surgeons are ecstatic about this relationship." "We are delighted to partner with Faith In Practice," said Dan Williamson, Zimmer Biomet's Group President, Joint Reconstruction. "This opportunity enables us to continue to provide our innovative products and solutions in a socially impactful manner and further expands our ongoing efforts to help improve the lives of people in underserved communities who typically do not have access to healthcare advancements." "We are incredibly grateful to Zimmer Biomet for making this commitment to serve those in great need in Guatemala. While Zimmer Biomet has always been generous in supporting medical volunteers who wish to serve those in need in developing nations, this new way of providing implants will leverage and expand its impact significantly. We applaud Zimmer Biomet's efforts and are honored to be its first partner in this new way of providing care to those who otherwise would have no access," said the Rev. Linda McCarty, President and Chief Executive Officer of Faith In Practice. About Faith In Practice The mission of Faith In Practice is to improve the physical, spiritual, and economic conditions of the poor in Guatemalathrough short-term surgical, medical, and dental mission trips and health-related educational programs. Faith In Practice's life-changing medical mission is to minister to the poor, while providing a spiritually enriching experience for its volunteers. Each year, more than 1,300 US volunteers serve through Faith In Practice, covering their own costs, taking vacation time, to serve. They are joined by more than 1,000 Guatemalan volunteers and two non-profit Guatemalan hospitals to provide care to the poor of Guatemala. For more information, visit www.faithinpractice.org. About Zimmer Biomet Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives. We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet. ZBH-Corp SOURCE Zimmer Biomet Holdings, Inc.
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Medtronic Announces FDA Approval of Infuse(TM) Bone Graft in New Spine Surgery Indications Using PEEK Interbody Implants
DUBLIN - April 30, 2018 - Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval of Infuse(TM) Bone Graft in new spine surgery indications. InfuseBone Graft is now approved for use with additional spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF 25(TM) and OLIF 51(TM)) and anterior lumbar interbody fusion (ALIF) procedures at a single level. This is the second expanded indication in just over two years. The new approved indications for InfuseBone Graft are:
- Use in OLIF 51 procedures with Divergence-L®Interbody Fusion Device at a single level from L5-S1.
- Use in OLIF 25 procedures with Pivox(TM) Oblique Lateral Spine System at a single level from L2-L5.
- Use in ALIF procedures with Divergence-LInterbody Fusion Device at a single level from L2-S1.
NEW YORK, April 30, 2018 /PRNewswire/ -- Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced results of three subanalyses from studies of coflex® that further validate the efficacy and benefit to patients with lumbar spinal stenosis. The data were presented during three scientific podium presentations at the 2018 International Society for the Advancement of Spine Surgery (ISASS), held April 11-13 in Toronto, Canada. "coflex® is the only posterior lumbar motion preservation solution with proven long-term outcomes for patients with moderate to severe spinal stenosis," said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. "Five years after the FDA IDE study, these analyses demonstrate that coflex leads to decreased operative time, less blood loss, shorter hospital stays and overall is significantly less invasive than fusion. As a result, coflex is more cost-effective for the healthcare system while preserving positive clinical outcomes. These findings are substantial and important because they reflect real-world considerations surgeons take into account when treating patients." The first podium presentation "5-year Follow-up of Interlaminar Stabilization Surgery in the ≤ 65 Year Old Patient: More Value, Less Cost," provided a sub-analysis of a cohort from the original multi-center, prospective, randomized, controlled Investigational Device Exemption (IDE) clinical trial that showed:
- coflex was significantly less-invasive as measured by shorter operative times, decreased blood loss, and shorter length of hospital stay than fusion.
- fusion surgery is more than $50,000 more expensive per procedure, as compared to decompression with coflex.
- coflex as an alternative to fusion in a clinically appropriate subset of LSS patients would favorably impact the total cost of care while preserving clinical outcomes.
- coflex is a significantly more cost-effective option for the healthcare system due to approximately half the operative time and a hospital stay that was almost two days shorter.
Related Linkshttp://www.paradigmspine.com Read More
Meditech Spine expands its lumbar plating options by adding the CURE LP iView and QMax to its growing portfolio of spinal implants
- CHF 17.0 million cash at year-end
- CHF 16.9 million equity raise in June 2017
- Standby equity facility established in November 2017 to increase financial flexibility
- Successful completion of merger with Xpand Biotechnology creating a leader in orthobiologics
- FDA approvals for MagnetOs Granules & Putty
- Prepared for U.S. launch of MagnetOs by end of June 2018
- Clinical development of Fibrin-PTH for spinal fusion on track
|In TCHF, IFRS|
|Research and development||(4,470)||(7,909)|
|General and administration||(15,242)||(17,070)|
|Net operating costs||(16,777)||(22,407)|
|Net financial income/(loss)||(350)||1,069|
|Net income/(loss) per share (in CHF)||(2.32)||(3.95)|
|Cash and cash equivalents, financial assets and trade and other receivables||17,024||13,034|
|Kuros Biosciences AG Michael Grau Chief Financial Officer Tel +41 44 733 47 47 email@example.com||Media & Investors Hans Herklots LifeSci Advisors +41 79 598 7149 firstname.lastname@example.org|
April 27, 2018
STRYKER TO HIGHLIGHT EXPANDING LINE OF 3D-PRINTED TRITANIUM® CAGES AT AANS
New Tritanium TL Curved Posterior Lumbar Cage to be previewedStryker’s Spine division will showcase its expanding line of Tritanium®cages, including the new Tritanium® TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion cage intended for use as an aid in lumbar fixation, at the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting, April 28–May 2, 2018, in New Orleans (booth No. 413). Tritanium Cages are built using Stryker’s proprietary Tritanium In-Growth Technology,1 a novel, highly porous titanium material designed for bone in-growth and biological fixation.1 AMagine™ technology, Stryker’s proprietary approach to implant creation using additive manufacturing, allows for the production of randomized yet reproducible porous structures.2 The result is Tritanium Technology, which features an interconnected architecture with rugged irregular pore sizes and shapes that is designed to mimic cancellous bone.2 The Tritanium material also may be able to wick or retain fluid in comparison to traditional titanium material.3 According to Bradley Paddock, president of the Spine division, Tritanium cages have been well-received by surgeon users and continue to gain momentum. Since their launch, the Spine division has sold nearly 26,000 Tritanium Posterior Lumbar (PL) and Tritanium Anterior Cervical (C) Cages, combined. “We are delighted to feature our growing family of Tritanium Cages at AANS this year and especially proud to introduce the Tritanium TL Curved Posterior Lumbar Cage,” Paddock said. “The new Tritanium TL Cage complements our Tritanium PL Cage, and together they offer alternative posterior lumbar solutions for spine surgeons and their patients.” The Tritanium TL’s new Anterior Placement System and cage design combine to enable the surgeon’s desired apophyseal placement. The Tritanium TL Cage is shaped for steerability and has a unique, curved shape and rounded teeth to facilitate multidirectional fixation. Stryker will host a Lunch-and-learn Seminar at AANS titled, “Evidence-Based Biomaterials in Spine,” on Monday, April 30 from 1:10–1:55 p.m. The seminar will be presented by Domagoj Coric, M.D., FAANS, neurosurgeon at Carolina Neurosurgery & Spine Associates in Charlotte, N.C. About Stryker Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at stryker.com and builttofuse.com. Follow the Spine division on Twitter @stryker_spine. References 1. PROJ43909 | Tritanium technology claim support memo. 2. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491. 3. TREP0000053045 | Tritanium Wicking Verification Test. Dr. Coric is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. Content ID: TRITA-PR-9_17426