30 Apr

DiscGenics Announces First Patient Treated in U.S. Clinical Trial of IDCT for Degenerative Disc Disease

SALT LAKE CITYApril 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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30 Apr

Orthofix Reports First Quarter 2018 Financial Results

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

Currency

Change

BioStim $ 46,163 $ 44,539 3.6 % 3.6 %
Extremity Fixation 27,504 23,945 14.9 % 4.3 %
Spine Fixation 20,707 19,267 7.5 % 7.2 %
Biologics 14,335 14,987 (4.4 %) (4.4 %)
Net sales $ 108,709 $ 102,738 5.8 % 3.3 %
Gross profit increased $4.4 million to $84.6 million. Gross margin decreased slightly to 77.8% compared to 78.0% in the prior year period due primarily to an unfavorable impact from sales mix this quarter. Non-GAAP net margin, an internal metric that the Company defines as gross profit less sales and marketing expenses, was $34.3 million compared to $31.6 million in the prior year period. The increase in non-GAAP net margin was primarily due to lower marketing expenses and decreased commission rates. Net income from continuing operations was $5.2 million, or $0.27 per share, compared to a loss of $2.3 million, or ($0.13) per share in the prior year period. Adjusted net income from continuing operations was $7.3 million, or $0.39 per share, compared to adjusted net income of $4.9 million, or $0.27 per share in the prior year period. EBITDA was $15.2 million, compared to $6.6 million in the prior year period. Adjusted EBITDA was $19.7 million, or 18.1% of net sales, for the first quarter, compared to $15.7 million, or 15.3% of net sales, in the prior year period. Liquidity As of March 31, 2018, cash and cash equivalents were $77.1 million compared to $81.2 million as of December 31, 2017. As of March 31, 2018, the Company had no outstanding indebtedness and borrowing capacity of $125 million under its existing credit facility. Cash flow from operations was ($3.6) million, an increase of $7.3 million, and free cash flow was ($7.0) million, an increase of $7.8 million when compared to the prior year period. 2018 Outlook For the year ending December 31, 2018, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.
(Unaudited, U.S. Dollars, in millions, except per share data) Low High
Full Year 2018 Outlook
Net sales $ 458.0 1 $ 464.0 1
Net income from continuing operations $ 24.8 2 $ 27.1 2
Adjusted EBITDA $ 85.5 3 $ 88.0 3
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
Net sales $ 113.0 6 $ 115.0 6
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%
Acquisition of Spinal Kinetics On April 30, 2018, the Company completed the acquisition of Spinal Kinetics, Inc., a privately held developer and manufacturer of artificial cervical and lumbar discs. Terms of the transaction included $45 million in cash plus up to an additional $60 million in future contingent milestone payments related to U.S. Food and Drug Administration approval of the M6-C® cervical disc and the achievement of certain future sales targets. These contingent milestones payments must be achieved within five years of closing. Inducement Grants Related to Acquisition of Spinal Kinetics As inducements to enter into employment with Orthofix, Mr. Afzal was granted 8,194 restricted shares of Orthofix common stock and options to purchase 28,624 shares of Orthofix common stock, and 67 additional employees joining from Spinal Kinetics were granted an aggregate of 14,887 restricted shares of Orthofix common stock. All awards vest in one-fourth annual increments beginning on the first anniversary of grant. The grants, which were approved by the Compensation Committee of Orthofix’s Board of Directors, were made under a standalone inducement plan approved pursuant to NASDAQ Marketplace Rule 5635(c)(4), but on terms substantially the same as grants made in the ordinary course under the Company's 2012 Long Term Incentive Plan. Domestication to Delaware As previously announced in February, the Company has been considering a redomicile from Curacao to Delaware. As a result of further analysis during the quarter, the Company has determined to pursue such a redomicile. The redomicile will be subject to approval by shareholders. If approved, the Company expects that the redomicile would be completed by the end of the year. Conference Call Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company's financial results for the first quarter of 2018 and the acquisition of Spinal Kinetics. Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 5288605. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 5288605. A webcast of the conference call may be accessed by going to the Company's website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.   READ THE REST HERE  

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30 Apr

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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30 Apr

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.
"Different spine patients can have very different surgical needs, so the more options surgeons have to combine a clinically-proven bone grafting technology like Infuse with different procedures and implants, the greater the likelihood of successful outcomes," said Dr. Richard Hynes, president and spine surgeon at the B.A.C.K. Center in Melbourne, Florida. "This latest approval addresses some fairly common degenerative spine surgical correction needs." InfuseBone Graft is used with certain Medtronic interbody fusion devices to treat lumbar degenerative disc disease. This condition can cause back and/or leg pain, as well as functional problems, such as tingling or numbness in the legs or buttocks or difficulty walking. "Infuse Bone Graft remains one of the most-extensively studied products in Spine that is commercially available today," said Doug King, senior vice president and president of Medtronic's Spine division, which is part of the Restorative Therapies Group at Medtronic. "The expanded approval with these PEEK devices for OLIF25, OLIF51, and ALIF procedures provide important options for surgeons and their patients." InfuseBone Graft is approved for certain spine, oral-maxillofacial and orthopedic trauma surgeries. Infuse has been on the market since 2002 and has been used in more than one million patients worldwide. The active ingredient in InfuseBone Graft is rhBMP-2 - a manufactured version of a protein already present in the body that promotes new bone growth. During surgery, it is applied to an absorbable collagen sponge (ACS). The ACS is a carrier to deliver the rhBMP-2 to the implant site and acts as a scaffold for the formation of new bone, and it will resorb, or disappear, over time. The Divergence-LInterbody Fusion Device and the Pivox Oblique Lateral Spine System incorporate the technology of Gary K. Michelson, M.D. About Medtronic Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Contacts: Victor Rocha Public Relations +1-901-399-2401 Ryan Weispfennig Investor Relations +1-763-505-4626

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30 Apr

Paradigm Spine Highlights Data Presented At ISASS 2018 Further Validating Decompression With coflex

NEW YORKApril 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.
The lightning podium presentation "Medical Cost Savings for Lumbar Spinal Stenosis Treated with Decompression and Interlaminar Stabilization as an Alternative to Fusion" examined the potential economic impact of utilizing decompression with coflex versus decompression with fusion. The analysis showed:
  • 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.
A second lightning podium presentation "Comparison of Decompression with Interlaminar Stabilization vs. Decompression with Fusion in Patients Requiring Surgical Treatment for Spinal Stenosis Grade I Spondylolisthesis at 5 Year Follow-Up" provided a sub-analysis of a cohort from the FDA IDE trial comparing the efficacy of decompression with coflex versus decompression with fusion and concluded:
  • 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.
About Lumbar Spinal Stenosis (LSS) Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion.  Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries. About Paradigm Spine, LLC: Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis.  The Company's signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com.   SOURCE Paradigm Spine, LLC

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30 Apr

Meditech Spine expands its lumbar plating options by adding the CURE LP iView and QMax to its growing portfolio of spinal implants

ATLANTAApril 30, 2018 /PRNewswire/ -- Meditech Spine, LLC, announced today it has received additional 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP iView and Cure LP QMax System clearance compliments Meditech's recent 510(k) of the CURE Lumbar Plate System in 2017 with additional plating options. The CURE LP allows surgeons to utilize the lumbar plating system along with its novel lumbar Talos® fusion devices, which are manufactured with the PEEK-OPTIMA™ HA Enhanced polymer.
The CURE LP is a low profile titanium plate that incorporates a proprietary, one-step locking mechanism to prevent screws anchored on the spine from loosening and backing out. The special 510(k) includes additional sizing options for surgeons. The CURE LP-iView is similar to the standard CURE LP anterior plate but includes a through hole with rib to nest with the Talos®-A (HA) Interbody Device. And, the CURE LP-QMax is a four hole direct lateral plate complimenting the previously cleared two hole plate. The CURE LP anterior plates, sacral plates and the new iView and Qmax plates will be combined in one tray with streamlined instruments to make it easier on hospital and surgery centers to process the system. All systems will be provided sterile packaged to aid with implant tracking while helping to reduce implant related infections. The CURE Lumbar Plate System is intended for use via a lateral or anterolateral surgical approach. With the introduction of the CURE Anterior Cervical Plating (ACP) last year, Meditech continues its philosophy of giving back which led to a partnership with CURE International, the namesake of the CURE ACP and CURE LP, an organization that serves children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care. "After the introduction in late 2017 with our CURE LP system, we have continued to listen to surgeons and build upon our existing platform by providing additional plating options. Surgeons now have the flexibility of choosing from multiple plate configurations for their patients that require supplemental fixation. When coupled with our Talos®-A (HA) Interbody Fusion Device, manufactured with our next generation osteoconductive polymer, we provide a full and robust system for surgeons who utilize the anterior and anteriorlateral approaches to treat degenerative spinal conditions," Eric Flickinger, Co-founder of Meditech Spine, noted. For more information visit Meditech Spine. ABOUT MEDITECH SPINE, LLC Meditech Spine, LLC, is a spinal device company developing innovative instrumentation for treating complex spinal issues. It partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech's pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies. CONTACT Meditech Spine, LLC (678) 974-5287 support@meditechspine.com Caption & Copyright: Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved. PEEK-OPTIMA™ is a trademark of Victrex plc or its group companies. All rights reserved.   SOURCE Meditech Spine, LLC

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30 Apr

Kuros Biosciences Reports Full-Year 2017 Results

Financial highlights

  • 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
Operational highlights
  • 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
SCHLIEREN (Zurich), Switzerland, April 30, 2018 (GLOBE NEWSWIRE) -- Kuros Biosciences (SIX:KURN) reported today its Full-Year 2017 Results, and the publication of its annual report. 2017 has been a transformative year for Kuros Biosciences, which successfully transitioned into a full-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration. MagnetOs Granules and MagnetOs Putty have been cleared by the U.S. Food and Drug Administration, and the Company is gearing up for their U.S. commercial launch in 2018. As a technology leader in synthetic and drug-based bone regeneration, Kuros is well-positioned to capture the commercial opportunity in the orthobiologics market, which is estimated to grow to more than $3 billion by 2030. Kuros intends to initially focus on spinal fusion, which represents 50% of the total orthobiologics market. Joost de Bruijn, Chief Executive Officer, said: “During 2017 we successfully set Kuros on a new course – one that is focused on cutting-edge orthobiologics, an important commercial opportunity. Our international team has responded with verve to our ongoing commercial transition, embracing their new challenges. As a result, we are well-positioned to execute on the commercial roll-out plan for MagnetOs in the U.S. and drive forward our exciting clinical program with Fibrin-PTH in spinal fusion, which represents a huge opportunity.” Financial position Cash and cash equivalents (including financial assets and trade and other receivables) as per December 31, 2017, amounted to CHF 17.0 million, compared with CHF 13.0 million as per December 31, 2016. The increase is mainly due to capital increases which off-set net operating cash. In 2017, Kuros received a milestone payment of TCHF 534 (TCHF 997 in 2016) from a collaboration partner. Operating costs for 2017 amounted to CHF 16.8 million, compared with CHF 22.4 million in the previous year. Research and development expenses decreased from CHF 7.9 million in 2016 to CHF 4.5 million in 2017. General and administrative expenses decreased from CHF 17.1 million in 2016 to CHF 15.2 million in 2017. During 2017, Kuros raised CHF 16.9 million in equity, and put a CHF 30 million equity financing facility in place to provide the Company with more financial flexibility.
Key figures   2017 2016
In TCHF, IFRS      
Revenue   534 1,061
Research and development   (4,470) (7,909)
General and administration   (15,242) (17,070)
Other income   2,935 2,572
Net operating costs   (16,777) (22,407)
Operating income/(loss)   (16,243) (21,346)
Net financial income/(loss)   (350) 1,069
Net income/(loss)   (16,484) (19,744)
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
Outlook In 2018, the Company aims to capitalize on the restructuring as it executes on its renewed focus on orthobiologics. This includes setting-up a U.S. commercial infrastructure to support the U.S. launch of MagnetOs, as well as the preparation of a Phase 2 clinical study for our drug-based Fibrin-PTH product candidate KUR-113 for spinal indications. Annual report The annual report of Kuros Biosciences is available online at www.kuros.ch/investors/reports-presentations.html. For further information, please contact:
Kuros Biosciences AG Michael Grau Chief Financial Officer Tel +41 44 733 47 47 michael.grau@kurosbio.com Media & Investors Hans Herklots LifeSci Advisors +41 79 598 7149 hherklots@lifesciadvisors.com
About Kuros Biosciences AG Kuros Biosciences (SIX:KURN) is focused on the development of innovative products for bone regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. Visit www.kurosbio.com for additional information on Kuros, its people, science and product pipeline. Forward-Looking Statements This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

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27 Apr

Mobius Imaging Receives 510(k) Clearance for Airo® CT Pediatric Applications

SHIRLEY, Mass.April 26, 2018 /PRNewswire/ -- Mobius Imaging, LLC, announced today that it has received 510(k) clearance for its Airo® Mobile CT Imaging System for pediatric applications. The Airo Mobile CT Imaging System previously received 510(k) clearance in 2013 for non-pediatric imaging and has become a market leader in intraoperative, image guided procedures in neuro-spine surgery. Airo diagnostic images also continue to be utilized for supporting applications in brachytherapy, radiation therapy and surgical imaging.  The ability to provide Airo Mobile CT imaging for pediatrics is an important milestone in the Company's ability to offer solutions for additional clinical segments and applications.  Pediatric patients can now receive the clinical benefits of Airo CT imaging for diagnostic and intraoperative procedures.
"There is an unmet need in being able to provide safe and reliable CT imaging for pediatric patients during various clinical procedures," explained Gene Gregerson CEO of Mobius Imaging. "CT systems must be designed and validated for safety and efficacy using different protocols than would be appropriate for adult patients.  We are delighted to now be able to offer the benefits of Airo Mobile CT imaging to clinicians and their pediatric patients." About Mobius Imaging Mobius Imaging develops, designs and manufactures advanced imaging technologies that fit seamlessly into existing medical workflows. The company's approach to technology – Intelligent Imaging – is designed to give healthcare practitioners the crisp, clear images they want, whenever and wherever they want them, without adding time or complexity to the procedure. From the OR to the ER to clinical settings of all kinds, Intelligent Imaging expands possibilities. Founded in 2008, the company now has over 130 Airo installations in 23 countries since 2014. Mobius Imaging is a registered trademark of Mobius Imaging, LLC. Contact: Alan Weinberg Director of Marketing aweinberg@mobiusimaging.com SOURCE Mobius Imaging, LLC

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27 Apr

CORRECTING and REPLACING Stryker to Highlight Expanding Line of 3D-Printed Tritanium® Cages at AANS

April 27, 2018

ALLENDALE, N.J.--(BUSINESS WIRE)--Reference 3 should read "TREP0000053045 | Tritanium Wicking Verification Test." (instead of RD0000050927 | Tritanium material capillary evaluation.). Also, Reference 4 has been removed. The corrected release reads:

STRYKER TO HIGHLIGHT EXPANDING LINE OF 3D-PRINTED TRITANIUM® CAGES AT AANS

New Tritanium TL Curved Posterior Lumbar Cage to be previewed

Stryker’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.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

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Sullivan & Associates Andrea Sampson, 714/374–6174 asampson@sullivanpr.com

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27 Apr

New Spinal Stimulation Technology More Effective in Reducing Pain in Patients with Intractable Spine or Limb Pain Compared to Medical Treatment

VANCOUVER, British ColumbiaApril 26, 2018 /PRNewswire-USNewswire/ -- Spinal stimulation increases the odds of pain relief more than medical therapy when patients are faced with intractable spine or limb pain. In a recent study, researchers made the following discoveries: 1) spinal stimulation compared to medical therapy significantly increased the odds of reducing pain by 50%; 2) spinal stimulation compared to medical therapy significantly reduced pain as measured by Visual Analogue Scale (VAS); and 3) using the common comparator of medical therapy, newer stimulation technology (eg, HF10, Burst, DRG) led to increased odds of pain relief compared to conventional spinal stimulation.
Presented today in a scientific poster at the American Academy of Pain Medicine 34th Annual Meeting, this abstract intends to increase awareness about spinal stimulation as an option to treat chronic pain. "Given the national opioid crisis, patients, physicians, policy makers, and payers are asking about viable alternatives to treat intractable pain. Spinal stimulation has demonstrated efficacy in a variety of difficult to manage chronic pain conditions," says Tim Lamer, MD, of the Mayo Clinic who led the research. "Our study is a comprehensive systematic review of the spinal stimulation literature spanning the past 30 years. We included only the highest quality studies consisting of Randomized Controlled Trials (RCTs). The results of our systematic review are that RCTs have demonstrated effectiveness and significantly greater odds of pain improvement with spinal stimulation compared to medical therapy in patients with painful diabetic neuropathy, complex regional pain syndrome, and pain in the setting of failed spine surgery. Recently published studies have shown that newer spinal stimulation technology such as dorsal root ganglion stimulation and Hf10 spinal stimulation compared to conventional spinal stimulation may have even greater success in achieving pain relief in properly selected patients." About AAPM The American Academy of Pain Medicine is the premier medical association for pain physicians and their treatment teams with some 2,000 members. Now in its 35th year of service, the Academy's mission is to advance and promote the full spectrum of multidisciplinary pain care, education, advocacy, and research to improve function and quality of life for people in pain. Information is available on the Academy's website at www.painmed.org. SOURCE American Academy of Pain Medicine

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