WASHINGTON — The Obama administration plans on Wednesday to propose expanding Medicare to cover programs to prevent diabetes among millions of people at high risk of developing the disease, marking the sixth anniversary of the Affordable Care Act with the prospect of a new benefit, federal officials said.

Sylvia Mathews Burwell, the secretary of health and human services, is scheduled to announce the proposal at a Y.M.C.A. here. Under the plan, Medicare would pay for certain “lifestyle change programs” in which trained counselors would coach consumers on healthier eating habits and increased physical activity as ways to prevent Type 2 diabetes, formerly called adult onset diabetes. Such programs have been found effective in people with a condition known as prediabetes, meaning that they have blood sugar levels that are higher than normal but not high enough to be considered diabetes.
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Services covered by the proposed diabetes prevention benefit could be provided in person or online. Omada Health, a San Francisco company founded in 2011 with venture capital, says it has provided diabetes-prevention services online to more than 45,000 people, most of whom had employer-sponsored insurance.
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“With Medicare coverage, our work with seniors is likely to grow dramatically,” said Mike Payne, the head of medical affairs at Omada.

Read More: ​http://nyti.ms/1RjPZpv

HHS Secretary Announces Expansion of Reimbursement for CDC-Recognized Diabetes Prevention Programs like Omada Health

San Francisco, CA (March 23, 2016) – Acknowledging diabetes as one of the most pressing issues facing the American healthcare system, U.S. Department of Health and Human Services Secretary Sylvia M. Burwell announced today that Medicare will begin reimbursing CDC-recognized providers like Omada Health for administering the Diabetes Prevention Program (DPP) to eligible beneficiaries. On the sixth anniversary of the Affordable Care Act, Secretary Burwell’s announcement underscores Medicare’s commitment to value-based care by extending the agency’s investment in chronic disease prevention.

Today, more than half of all Americans over the age of 65 have prediabetes, and fewer than one in ten are aware they have the condition. Without intervention, one third of those with prediabetes will likely progress to type 2 diabetes in the next three years. In 2014, Medicare spent more than $15,700 per beneficiary with diabetes, and according to the Diabetes Care Project, one of every three dollars spent by Medicare goes to treating individuals with the condition.
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“Today’s commitment by HHS quite literally extends a lifeline to 22 million American seniors with prediabetes,” said Omada Health co-founder and CEO Sean Duffy. “We feel fortunate to have the opportunity to work with CMS, Medicare Advantage plans, health systems, and physicians across the country to make a profound impact in these individuals’ lives. By elevating evidence-based diabetes prevention as the reimbursed standard of care, Secretary Burwell has acknowledged the urgency of addressing what has become a national epidemic. We look forward to continuing to provide data, evidence, and implementation insight to the team at HHS to ensure that the diabetes prevention benefit is implemented effectively, and reaches as many eligible beneficiaries as possible.”

Read More: https://omadahealth.com/news/medicare-will-cover-diabetes-prevention-program-for-at-risk-seniors

Monteris Medical has opened its new headquarters facility in Plymouth.

The medical device manufacturer specializes in neurosurgical technology and sells the NeuroBate System, which provides controlled thermotherapy for neurological tissue like brain lesions.
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After four years of rapid growth, the company left its old 7,000-square-foot facility in Plymouth for the new 16,000-square-foot headquarters. The new offices have space to accommodate further hiring.
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"As part of an established and growing medical technology corridor with a highly skilled workforce, Plymouth is a perfect location to continue our next phase of growth and development," President and CEO John Schellhorn said in a prepared statement. "We have been fortunate to expand rapidly over the previous four years and are excited to make our new home in a facility that will accommodate our expanding employee base and serve as our global operations center."

Read More: ​http://www.bizjournals.com/twincities/news/2016/03/22/new-monteris-medical-headquarters-plymouth-photos.html

REDWOOD CITY, Calif., March 17, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced dosing of the first patient in its Phase 1b clinical trial of OncoMed's investigational agent demcizumab (anti-DLL4, OMP-21M18), with Merck's anti-Programmed Cell Death 1 (PD1) therapy pembrolizumab (KEYTRUDA®).  The combination of these agents may act as a double blockade for cancer-induced immune suppression with potential application to a number of solid tumor cancers.

The Phase 1b clinical trial is enrolling patients with advanced or metastatic solid tumors to receive escalating dose cohorts of demcizumab plus an approved dose of pembrolizumab.  Once an optimal combination dose is established, three expansion study cohorts will be enrolled in non-small cell lung cancer (NSCLC), anti-PD1 refractory solid tumors and castrate-resistant prostate cancer. 
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The primary objective of the trial is to determine the safety and tolerability of the demcizumab-pembrolizumab combination.  The trial will also look at comparative pharmacokinetic profiles, incidence of antibodies against demcizumab or pembrolizumab, biomarker and immunological response, response rates and survival outcome in patients with advanced solid tumors, NSCLC, castrate-resistant prostate cancer and anti-PD1 antibody refractory cancers. 

Read More: ​http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=961144

SUNNYVALE, Calif., March 15, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced CE Mark approval for its next generation ENROUTE Transcarotid Neuroprotection System (NPS).  The ENROUTE NPS remains the only device specifically designed and indicated for TransCarotid Artery Revascularization (TCAR), a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. 

In partnership with treating physicians and based on feedback from over 700 TCAR procedures, the ENROUTE NPS was enhanced and upgraded to provide physicians with an even more dependable and easy-to-use system to treat their patients in the safest manner possible.  The ENROUTE NPS allows the physician to directly access the common carotid artery in the neck and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting Silk Road's ENROUTE® Transcarotid Stent. 

The first TCAR procedures with the new ENROUTE NPS were recently performed in leading European hospitals including the Virgen de la Salud Hospital in Toledo, Spain, Klinikum rechts der Isar (Technische Universität München) in Munich, Germany, Augusta Krankenhaus in Dusseldorf Germany, John Paull II Hospital in Krakow, Poland and Gent University Hospital in Gent, Belgium.     

Read More: ​http://www.prnewswire.com/news-releases/silk-road-medical-announces-ce-mark-approval-and-first-patients-treated-with-the-next-generation-enroute-transcarotid-neuroprotection-system-300236473.html

NEW YORK--(BUSINESS WIRE)--Remedy Pharmaceuticals, a privately-held, Phase 3-ready pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced that the Company appointed Thomas MacAllister as Vice President of Research and Development, and General Counsel.

“As we begin preparations for commencement later this year of our Phase 3 clinical trial in patients with large hemispheric stroke, Tom’s wealth of CNS-related clinical trial experience will be indispensable,” states Sven Jacobson, CEO of Remedy Pharmaceuticals. “We’re therefore delighted to welcome him to the senior management team.”

Read More: ​http://www.businesswire.com/news/home/20160315005038/en/Remedy-Pharmaceuticals-Appoints-Thomas-MacAllister-Vice-President

Projects Two Years' Cash Runway — without Partner-related Milestones/Opt-ins
OncoMed Management to Host Conference Call/Webcast this Afternoon at 4:30 p.m. ET/1:30 p.m. PT

REDWOOD CITY, Calif., March 10, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel cancer stem cell (CSC) and immuno-oncology therapeutics, today announced financial results for the year and quarter ended December 31, 2015 and provided 2016 guidance.  As of December 31, 2015, pro-forma cash and marketable securities totaled $227.3 million, exceeding the company's 2015 guidance of year-end cash of greater than $120 million.  Full-year cash expense was $101.1 million, in line with the 2015 cash expense guidance of $100-$110 million. 
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2016 Financial Guidance
For the full year 2016, based on its current plans and expectations, OncoMed anticipates total cash expenses in the range of approximately $110-$120 million.  OncoMed projects a 2016 year-end cash balance of more than $100 million, before considering the receipt of any potential collaboration milestones or opt-in payments. Potential milestone and opt-in payments over the course of 2016, 2017, and 2018 total over $270 million.  Existing cash is anticipated to fund company operations for at least two years, without taking into account potential future milestones or payments from partners.  This is an increase from the 1.5 years of cash guidance announced in January 2016 and is the result of pipeline and budget prioritization and careful fiscal management.

"Having extended our runway to greater than two years cash — without taking into account potential milestones over the course of those two years — OncoMed is well positioned to execute on plan and continue to build value through the advancement and growth of our research and development pipeline," said Paul J. Hastings, Chairman and Chief Executive Officer.  "We have a number of things to look forward to in 2016, including the advancement of three randomized Phase 2 trials, data from several earlier-stage clinical programs, and two new immuno-oncology programs moving toward IND filings in late 2016/early 2017."

Read More: ​http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=960007

NEW YORK, New York, March 4, 2016 — Remedy Pharmaceuticals, a privately-held, pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which took place on March 2, 2016.
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“Our End-of-Phase 2 meeting was a decisive milestone for the Company as we advance the clinical development of CIRARA™,” states Sven Jacobson, Chief Executive Officer of Remedy Pharmaceuticals. “We are pleased with the FDA’s guidance on our Phase 3 trial design in patients with large hemispheric stroke and we look forward to initiating the study as quickly as possible.”

Read More: ​http://www.remedypharmaceuticals.com/press-releases/remedy-pharmaceuticals-announces-successful-completion-of-end-of-phase-2-meeting-with-fda-on-a-novel-drug-treatment-for-cns-related-edema