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The Vertical Group
Investing for Innovation

Silk Road Medical Appoints Ground Breaking Innovator as Chief Technology Officer

7/23/2014

 
Via: PRNewswire
SUNNYVALE, Calif., July 23, 2014 /PRNewswire/ -- Silk Road Medical, Inc., a developer of advanced devices for the transcarotid treatment of intra- and extra-cranial cerebrovascular disease, announced today the appointment of Michael P. Wallace to the position of Chief Technology Officer.  In this new role, Michael will lead the company's Research and Development efforts across its family of transcarotid access and treatment devices.

Prior to joining Silk Road Medical, Michael was the Vice President of Research and Development at Boston Scientific's Electrophysiology Division and previously held senior technical leadership roles at Baxano Surgical, Inc., BARRx Medical, and Boston Scientific Neurovascular / Target Therapeutics. He has over 20 years of experience in the medical device field and holds over 120 issued or pending US patents.

Read More: http://www.prnewswire.com/news-releases/silk-road-medical-appoints-ground-breaking-innovator-as-chief-technology-officer-268257952.html

OncoMed Pharmaceuticals Initiates Randomized Phase 2 "ALPINE" Clinical Trial of Tarextumab (Anti-Notch 2/3, OMP-59R5) for Pancreatic Cancer

7/16/2014

 
Via: Yahoo Finance
REDWOOD CITY, Calif., July 16, 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 that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE" (Antibody therapy in first-LinePancreatic cancer Investigating anti-Notch Efficacy and safety) clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab (OMP-59R5), being studied for the treatment of pancreatic cancer.

Tarextumab is being tested in combination with Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival (PFS) of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.

Read More: http://finance.yahoo.com/news/oncomed-pharmaceuticals-initiates-randomized-phase-123000405.html

Silk Road Medical Completes Enrollment In The ROADSTER Clinical Trial For Carotid Artery Disease

7/16/2014

 
Via: PRNewswire
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

Omada Health Endorsed by the National Association of Chronic Disease Directors as a Premier Online Provider for Patients Seeking the Diabetes Prevention Program (DPP)

7/15/2014

 
Via: Business Wire
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

OncoMed Pharmaceuticals Granted Broad FZD-Fc Composition-of-Matter and Use Patent

7/2/2014

 
Via: Yahoo Finance
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

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