|Given Imaging Announces New Data On SmartPill(R); XenoPort Reports Top-Line Results of Phase 3 Trial of Arbaclofen Placarbil for Spasticity|
|By Mary Davila|
|Monday, 20 May 2013 18:07|
Given Imaging Ltd, (Nasdaq: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, announced several studies confirming an expanded role for SmartPill in diagnosing gastrointestinal motility disorders. All data were presented at Digestive Disease Week® (DDW) taking place May 18 - 21, 2013 at the Orange County Convention Center, Orlando, FL where Given Imaging is exhibiting at booth #1059 throughout the conference.
"The SmartPill motility monitoring system gives us a complete GI profile that allows us to recognize multiregional transit irregularities in patients with possible upper or lower GI dysmotility," said Braden Kuo, M.D., Director, Gastrointestinal Motility Laboratory, Massachusetts General Hospital. "These new studies add to the growing body of data showing that SmartPill is an extremely valuable tool enabling us to diagnose and treat motility disorders for better patient care."
A key poster presentation, Wireless Motility Capsule Alters Diagnosis and Affects Clinical Management in Patients with Suspected Gastrointestinal Dysmotility, poster Mo2092, presented by Shreya Raja, M.D., Division of Gastroenterology and Hepatology, Johns Hopkins School of Medicine, and colleagues, retrospectively examined how SmartPill findings affect clinical care. The study reviewed numerous data points including pressure, pH and temperature data collected by SmartPill to determine the diagnostic yield of wireless motility capsule and assess changes in 51 consecutive patients with suspected dysmotility. Clinical management decisions after the SmartPill procedure, including medication changes, referrals for additional diagnostic tests, and outside referrals, were also analyzed. Results show that data collected by SmartPill impacts patient care by altering diagnosis and clinical management. Alteration in diagnosis was frequent and change in medication was made for the majority of patients with abnormal testing results. Furthermore, normal SmartPill testing changed clinical management in over 50% of cases.
XenoPort (Nasdaq: XNPT) announced top-line results from its pivotal Phase 3 clinical trial of arbaclofen placarbil (AP) for the treatment of patients with spasticity due to multiple sclerosis (MS). The trial was unsuccessful in demonstrating that AP provided statistically significant improvement relative to placebo in the co-primary endpoints of the study.
Ronald W. Barrett, Ph.D., chief executive officer of XenoPort, stated, "We are obviously disappointed that the co-primary efficacy endpoints were not met. Based on the results of the study, we have decided to terminate further investment in this program. We will be working diligently to shut down all activities related to AP development, and plan to provide an update in the future on the impact of these expected savings on our cash burn guidance.
We remain committed to allocating our resources to build value through the focused commercialization of Horizant and advancing the development of our novel fumarate product candidate, XP23829."
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with neurodegeneration and apoptosis, today announced that Chief Executive Officer Gerald Commissiong will present at the 2nd Annual Marcum MicroCap Conference on Thursday, May 30, 2013, at the Grand Hyatt Hotel in New York City.
Atossa Genetics, Inc.(NASDAQ: ATOS), the Breast Health Company™, today announced that Dr. Steven Quay, chairman, CEO and president, will be presenting at the Sidoti Semi-Annual Microcap Conference on Friday, June 7, 2013, at 2:00 p.m. Eastern Time, at the Grand Hyatt Hotel in New York City.
Baxter International Inc. (NYSE: BAX) announced today that it will present at the Deutsche Bank 38th Annual dbAccess Health Care Conference on Wednesday, May 29, 2013 at 7:00 a.m. (CT).
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MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that it has secured a revolving line of credit with Bank of America.
MusclePharm Corporation (OTCQB: MSLP), a fast growing company that develops and markets sports nutritional supplements which address active lifestyles, announced today it has been invited to present at the 14th Annual B. Riley Investor Conference.
OvaScienceSM, (NASDAQ: OVAS), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today announced that OvaScience Co-Founder Jonathan L. Tilly, Ph.D., has been named to The Boston Globe’s 2013 “The Innovators” feature.
Precision Optics Corporation, Inc. (OTCQB: PEYE) (the "Company") announces operating results for the third quarter and nine month period ended March 31, 2013.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today PRIME clinical study results for Soluble Ferric Pyrophosphate (SFP) at the 50th ERA-EDTA congress in Istanbul, Turkey.
Rockwell Medical, Inc. (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today the closing of the sale of 13,196,721 common shares, including 1,721,311 shares of common to cover overallotments, at $3.05 per share in an underwritten public offering for an aggregate offering amount of approximately $40.3 million.
SK3 Group, Inc. (OTC Pink: SKTO) announces that it has secured an additional 10 acres of real estate in Northern California to develop and manage state-of-the-art growing facilities for its member collectives.