SUNNYVALE, Calif., July 16, 2014 /PRNewswire/ -- Silk Road Medical, Inc. announced today the completion of enrollment in its pivotal ROADSTER study. The trial was the first of its kind to study the treatment of carotid artery stenosis by placing a stent via direct access to the common carotid artery in the neck in an entirely new minimally invasive procedure.  The device under study is the Company's ENROUTE™ Transcarotid Neuroprotection System (NPS) which incorporates proven surgical principles to protect the brain from a stroke during carotid angioplasty and stenting, and features a mechanism to divert dangerous debris away from the brain by temporarily reversing blood flow.   Data from the trial will be used to support 510(k) clearance of the ENROUTE Transcarotid NPS as well as PMA approval of the ENROUTE Transcarotid Stent System.

The carotid arteries, located on either side of the neck, are the main conduits for blood flow to the brain. Plaque formation in these arteries can put patients at risk for stroke. Stroke is the nation's third leading cause of death, killing nearly 160,000 Americans every year.  Approximately 130,000 Americans are treated for narrowing of the carotid arteries each year. 

Read More: http://www.prnewswire.com/news-releases/silk-road-medical-completes-enrollment-in-the-roadster-clinical-trial-for-carotid-artery-disease-267377181.html

SAN FRANCISCO--(BUSINESS WIRE)--Omada Health, a pioneer in the emerging field of digital therapeutics, today announced the National Association of Chronic Disease Directors (NACDD) has selected its flagship product, Prevent, an online program to fight prediabetes, as a premier solution for patients seeking an online Diabetes Prevention Program (DPP).

“The NACDD’s endorsement of Prevent is a tremendous validation of how digital therapeutics can revolutionize behavioral medicine and help combat chronic disease at scale”

The mission of the NACDD is to work with public health departments, associations and private partners across the United States to prevent and control chronic disease. One of NACDD’s areas of focus is the prevention of type 2 diabetes. People with diagnosed diabetes, on average, have medical expenditures approximately 2.3 times higher than those without diabetes. Thirty-seven percent of American adults have prediabetes (the clinical precursor to type 2 diabetes), and without lifestyle changes to improve their health, 15% to 30% of those will develop type 2 diabetes within five years.

Read More: http://www.businesswire.com/news/home/20140715006190/en/Omada-Health-Endorsed-National-Association-Chronic-Disease#.U8bQQvldWsA

REDWOOD CITY, Calif., July 2, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced the issuance of a broad U.S. patent relating to FZD-Fc soluble receptors, including OncoMed's clinical-stage candidate ipafricept (FZD8-Fc, OMP-54F28). The new patent, U.S. Patent No. 8,765,913, includes claims covering certain FZD-Fc compositions of matter, as well as claims covering methods of treating cancer with such soluble receptors. Polynucleotides encoding the claimed FZD-Fc polypeptides and cells producing such polypeptides are also covered.

Read More: http://finance.yahoo.com/news/oncomed-pharmaceuticals-granted-broad-fzd-123000431.html

MINNEAPOLIS, June 17, 2014 /PRNewswire/ -- Techne Corporation TECH +2.06% (d/b/a Bio-Techne) announced today that it has agreed to acquire ProteinSimple for $300 million in cash. The closing of the acquisition is subject to the satisfaction of customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.  The acquisition is not subject to any financing contingencies. The transaction will be financed through a combination of cash on hand and a new revolving line of credit facility that Bio-Techne expects to obtain prior to the closing of the acquisition.

ProteinSimple develops and commercializes proprietary systems and consumables for protein analysis that ultimately help reveal new insights into the true nature of proteins.  ProteinSimple tools have revolutionized the analysis of proteins and provide a level of reliability, ease of use and performance that improves overall productivity and consistency in lab results.

Read more: http://www.marketwatch.com/story/bio-techne-announces-agreement-to-acquire-proteinsimple-2014-06-17

REDWOOD CITY, Calif., June 4, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, will present new data at the upcoming 19th European Hematology Association (EHA) Congress related to the company's anti-Notch1 (OMP-52M51) clinical-stage program.

At the EHA Congress, OncoMed will present the first data for its proprietary Next Generation DNA Sequencing (NGS) assay developed with MolecularMD (Portland, OR) to identify Notch1 mutation status in patients with certain hematologic malignancies. Notch1 mutations have been linked to more refractory lymphoid malignancies, such as chronic lymphocytic leukemia (CLL), mantle cell lymphoma, and others, putting patients at greater risk for poor outcomes and reduced overall survival. OncoMed's Notch1 mutation biomarker assay is being developed as a companion diagnostic to identify patients whose cancer may be more likely to benefit from treatment with the company's anti-Notch1 antibody, OMP-52M51. OncoMed is currently conducting two separate Phase 1 clinical studies of its Notch1 targeting antibody in patients with certain advanced solid and hematologic tumors, respectively.

Read more: http://investor.shareholder.com/oncomed/releasedetail.cfm?releaseid=852391

REDWOOD CITY, Calif., May 28, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that Paul J. Hastings, OncoMed's Chairman and Chief Executive Officer, will present an overview of the company at the Jefferies 2014 Global Healthcare Conference being held in New York City.

Mr. Hastings will speak on Wednesday, June 4, 2014 beginning at 4:00 pm EDT. To access the live webcast and subsequent archived recording for the presentation, please visit the Investors tab on the OncoMed website at www.oncomed.com.

Read more: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=850868

SAN DIEGO, May 27, 2014 /PRNewswire/ -- Volcano Corporation VOLC +2.09% , a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has signed an agreement to acquire AtheroMed, Inc., a privately-held company that has developed the Phoenix® Atherectomy System used in the treatment of peripheral artery disease (PAD).

The Phoenix, which received 510(k) clearance in January 2014 and has a CE Mark, enables physicians to treat PAD with a low profile peripheral atherectomy catheter that continuously removes diseased material as it is debulked. The device has reimbursement in the U.S. and select countries in Europe.

Under terms of the agreement, Volcano will pay $115.0 million in cash at closing, which is expected to occur in the current quarter. In addition, Volcano will make a $15 million milestone payment if a Phoenix device currently before the FDA receives clearance by November 15, 2014. This application covers design for manufacturing improvements to the currently approved device. In addition, the agreement calls for potential future revenue-based milestone payments by Volcano to AtheroMed.

Read more: http://www.marketwatch.com/story/volcano-corporation-announces-agreement-to-acquire-atheromed-2014-05-27

REDWOOD CITY, Calif., May 14, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today highlighted data from several clinical studies that will be presented at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting being held May 30 - June 3, 2014 in Chicago, IL. OncoMed will present new clinical data, as follows:

• Fzd8-Fc (OMP-54F28) Phase 1a trial in patients with advanced solid tumors (oral presentation);
• Anti-Notch 2/3 (OMP-59R5) Phase 1b/2 PINNACLE study in small cell lung cancer; and
• Demcizumab (anti-DLL4, OMP-21M18) Phase 1b study in non-small cell lung cancer.

"Across our clinical pipeline, we are obtaining new data for OncoMed's anti-cancer stem cell therapeutics," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "The results being presented at ASCO for several OncoMed candidates demonstrate acceptable safety and tolerability profiles with manageable or reversible side effects observed, both as single agents and in combination with standard chemotherapy. Fzd8-Fc, anti-Notch 2/3 and demcizumab are all showing early indications of biomarker and anti-tumor activity."

Read more: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=848073

REDWOOD CITY, Calif., April 23, 2014 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced that several abstracts have been accepted for presentation at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting being held May 30 - June 3, 2014 in Chicago, IL.

OncoMed will present new clinical data from its ongoing studies, including the Phase 1b study of demcizumab (OMP-21M18, anti-DLL4) in non-small cell lung cancer (NSCLC), the Phase 1/2 PINNACLE trial of OMP-59R5 (anti-Notch 2/3) in small-cell lung cancer (SCLC) and the Phase 1 trial of OMP-54F28 (FZD8-Fc) in patients with advanced solid tumors. The list of abstracts and timing of the presentations is provided below.

Read more: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=841935

This guest article is by Sean Duffy, CEO and Co-Founder, Omada Health

Three out of four Americans will die of a disease that could be avoided—if only they could re-route their unhealthy habits. A new category of medicine, digital therapeutics, wants to change the course of these conditions — and of history.

Doctors have known for decades that, in order to prevent disease or its complications, they were going to have to get into people’s living rooms and convince them to change everyday behaviors that would very likely kill them. To that end, back in the early ’90s, health institutions started trying to intervene largely via the cutting-edge technology that existed at the time: phone calls. At-risk populations were dialed up and encouraged to take steps that could ward off heart disease, diabetes complications, lung cancer and other avoidable conditions that cause 75% of Americans to die prematurely.

As you can imagine, these calls largely flopped. A phone interaction led by a stranger who interrupts your dinner hour, no matter how well-intentioned, felt like more like an intrusion than meaningful support.

Read more: http://www.forbes.com/sites/sciencebiz/2014/04/17/what-if-doctors-could-finally-prescribe-behavior-change/#what-if-doctors-could-finally-prescribe-behavior-change