Angel® Catheter Pivotal Study Published in Journal of Vascular and Interventional Radiology

Thursday, June 29, 2017

GOLDEN, Colo., June 29, 2017 /PRNewswire/ -- Bio2 Medical today announced the results of the Angel® Catheter pivotal study, "Evaluation of a Device Combining an Inferior Vena Cava Filter and a Central Venous Catheter for Preventing Pulmonary Embolism Among Critically Ill Trauma Patients," published in the Journal of Vascular and Interventional Radiology (JVIR). The Angel® Catheter met all safety endpoints and demonstrated a significant reduction in clinically significant and fatal pulmonary embolism (PE). The novel device was tested in a single arm, multicenter clinical trial in which it was inserted bedside in the intensive care unit (ICU) without fluoroscopy, and safely retrieved from all patients prior to discharge. The study included 163 critically ill patients with high risk of acute PE and contraindications to anticoagulation, with 151 (93%) critical trauma patients. In this trauma group, 129 (85%) patients suffered from spinal or head trauma, 102 (79%) of which also had intracranial bleeding. With no catheter-related blood stream infections (CRBSI), the Angel® Catheter successfully averted PEs in 14 (11%) of the 129 patients with a pre-removal cavogram. The data will be presented at the 76th Annual Meeting of AAST and Clinical Congress of Acute Care Surgery. 

AmideBio to present a novel treatment for hyperinsulinism at the International Congenital Hyperinsulinism Conference July 15-16, 2017 at the Stockton Seaview Hotel, Galloway, New Jersey

Monday, June 26, 2017

BOULDER, CO, June 26, 2017 – AmideBio, LLC, a privately-held biopharmaceutical company, today announced that AmideBio’s Chief Technology Officer, Dr. Michael H. B. Stowell will present a talk titled “Novel Pumpable Glucagons for Treatment of Hyperinsulinism” at the 2017 International Congenital Hyperinsulinism Conference July 15-16, 2017, hosted by the Children’s Hospital of Philadlephia (CHOPS) and Congenital Hyperinsulinism International (CHI), a charitable organization dedicated to improving the lives of children, adults, and families living with congenital hyperinsulism. 

ARCA Biopharma Announces Database Lock for GENETIC-AF Phase 2B Interim Efficacy Analysis – DSMB Recommendation Anticipated in August 2017

Tuesday, June 20, 2017

WESTMINSTER, Colo., June 20, 2017 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq:ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced database lock for the GENETIC-AF Phase 2B interim efficacy analysis, to be conducted by the trial Data Safety Monitoring Board (DSMB). GENETIC-AF is a seamless design Phase 2B/3 clinical trial evaluating GencaroTM (bucindolol hydrochloride) as a potential treatment for atrial fibrillation (AF). The Company expects to announce the DSMB’s recommendation based on this interim analysis in August 2017. The Gencaro development program has previously been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). 

Biodesix's GeneStrat® Liquid Biopsy Test Earns Approval from NY State-CLEP

Monday, June 19, 2017

June 19, 2017, Boulder, Colorado…Biodesix, Inc. announced today that the GeneStrat test has been approved byNew York State'sClinical Laboratory Evaluation Program (CLEP). Approval for the GeneStrat test by CLEP is the most recent of a number of demanding certifications earned by Biodesix’s onsite laboratory, which has now been certified by CLEP, CAP, CLIA, ISO 35485 and five other states.  

Clovis's ovarian cancer drug set for label expansion, shares soar

Monday, June 19, 2017

Clovis Oncology Inc said on Monday late-stage data on its already-approved ovarian cancer drug showed that the treatment could benefit four times as many patients, sending shares of the U.S. biotech soaring 50 percent. 

Ocugen Raises $7.5M for Clinical Development of Ocular Diseases Pipeline

Thursday, June 15, 2017

Eye disorders biopharma Ocugen raised $7.5 million in a Series B round of fundraising to support development of its clinical and preclinical pipeline of treatments for sight-threatening diseases. The financing was led by Turkish pharma firm Abdi Ibrahim and Kazakhstan-based JSC Lancaster Group. Current investors Frank Leo and Dr. John Zhang also participated. Ocugen closed a $6 million Series A round of fundraising in December 2016. 

Needle-free Injection Linked to Increasing Workplace Flu Shot Compliance

Tuesday, June 13, 2017

GOLDEN, Colo. – June 13, 2017 – PharmaJet® Inc., the maker of needle-free injection technology, announced today that ONdrugDelivery published their study, entitled Needle-free Injection in Workplace Influenza Clinics, in its May issue

Colorado BioScience Association Recognizes 2017 Boettcher Investigators

Tuesday, June 13, 2017

DENVER, June 13, 2017 — The Colorado BioScience Association on Tuesday commended the newest class of Boettcher Investigators and expressed its gratitude to the Boettcher Foundation for its continued support of scientific innovation in Colorado. 

$140M debt refinancing announced by Spectranetics

Monday, June 12, 2017

An amendment to Spectranetics' existing credit facilities has increased the company's total credit facility to $140 million, which consists of a $90 million term loan and $50 million revolving credit line. The new facility replaces the company's earlier $60 million term loan and $50 million revolver, with the term loan's maturity extended to March 2021. 

Biodesix® and Positive Bioscience Announce Partnership to Bring Cancer Tests to India

Monday, June 12, 2017

BOULDER, Colo., June 12, 2017 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Boulder, CO, USA) and Positive Bioscience (Mumbai, India) announced today that they have entered into an agreement where Positive Bioscience will make Biodesix’s GeneStrat® and VeriStrat® liquid biopsy tests for non-small cell lung cancer (NSCLC) patients available in India. All testing will be performed at Biodesix’s CLIA/CAP/CLEP/ISO certified laboratory in Boulder, Colorado, USA.