First New Device Trial Completed for Home Hemodialysis In 15 Years

SAN JOSE, Calif., Nov. 7, 2019 /PRNewswire/ -- Outset Medical, a commercial-stage company delivering first-of-its-kind technology into the growing, global, dialysis market today announced publication of a multicenter, prospective, open-label study in Hemodialysis International.  Titled "Safety and Efficacy of the Tablo Hemodialysis System for In-center and In-home hemodialysis," the 30-patient study met both the safety and efficacy endpoints.  Tablo is currently FDA-cleared for use in hospitals and clinics and is under evaluation by FDA for use in the home.

​Over 21 consecutive weeks, patients went through four treatment periods in which hemodialysis was prescribed four times weekly:  one-week Run-In; eight-week In-Center; four-week Transition; eight-week In-Home.  The data showed a mean weekly standard Kt/V ≥ 2.8 for participants during the In-Center and In-Home treatment periods (compared to the trial endpoint of a standard Kt/V ≥ 2.1) and delivered ultrafiltration (UF) within 10% of prescribed UF.  There were no device-related pre-specified adverse events throughout the trial.  All patients who started the home arm with Tablo completed it, resulting in a 0% home arm drop-out rate.  

Read More: https://www.prnewswire.com/news-releases/results-from-prospective-multicenter-trial-evaluating-the-use-of-the-tablo-hemodialysis-system-for-home-dialysis-released-at-the-american-society-of-nephrology-scientific-meeting-300954040.html?tc=eml_cleartime

SUNNYVALE, Calif., Oct. 29, 2019 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today reported financial results for the three months ended September 30, 2019.

“Our third quarter results reflect strong execution across our entire organization,” said Erica Rogers, Chief Executive Officer. “With our intense focus on building best-in-class clinical evidence and executing our commercial strategy, TCAR is finding its place prominently in the carotid treatment continuum. While we are still in early in our journey to reach standard of care, we are well positioned for continued progress.”

Read More: https://www.globenewswire.com/news-release/2019/10/29/1937423/0/en/Silk-Road-Medical-Reports-Third-Quarter-2019-Financial-Results.html

FreeStyle Libre's glucose readings, trends and patterns will all be incorporated into Omada's app.

This morning med tech giant Abbott announced a new deal with chronic care management company Omada Health that will integrate Abbott’s FreeStyle Libre continuous glucose monitor (CGM) with Omada's health coaching platform. 
Going forward, eligible users with Type 2 diabetes will have the option to integrate data from their FreeStyle Libre, including glucose reading, trends and patterns, with Omada’s platform. When users enroll in the program, they can access a virtual physician, who can prescribe them the CGM. 

Read More: https://www.mobihealthnews.com/news/north-america/abbott-freestyle-libre-system-integrate-omada-health-app

Alongside a deeper collaboration with the not-for-profit system, Omada expects the funds to fuel expansion of its integrated digital care program.

Digital chronic disease management company Omada Health has added onto June’s $73 million funding round with a new strategic investment from Intermountain Ventures. The terms of the deal were not disclosed.

WHAT THEY DO
Omada pitches its digital coaching programs as a scalable and convenient approach to chronic disease management. The company’s products address hypertension, Type 2 diabetes, mental health conditions and other health needs. The company also implements connected technology to track participants and hold them accountable — for instance, a wireless scale, a pedometer, and a mobile app to track food and activity for its diabetes program.

Read More: https://www.mobihealthnews.com/news/north-america/omada-health-receives-strategic-investment-intermountain-ventures

Joe Wright of Wytheville went to his ophthalmologist with a case of pink eye. What Joe, 83, came away with was, in his own words, “a pretty big shock.”

Joe’s eye doctor had discovered a retinal hemorrhage and suspected a blocked artery, referring Joe for further testing. “I didn’t realize eye trouble could mean my artery was blocked,“ Joe remembers. Testing, however, revealed a left carotid artery that was almost 100 percent blocked.

Joe, as it turned out, was a perfect candidate for a less invasive type of surgery called transcarotid artery revascularization, or TCAR. It’s a procedure doctors at Carilion Clinic’s Aortic Center were among the first in the country to perform. Carilion Roanoke Memorial is a TCAR Center of Excellence, boasting one of only a few board-certified vascular surgeons with fellowship training in vascular interventional radiology in the U.S.

Read More: https://reports.carilionclinic.org/medicine-technology/working-against-flow-creates-wonderful-breakthrough?_ga=2.257002955.1321455121.1564769191-1617186008.1564769191

Nearly 800,000 Americans have a stroke each year. Sadly, about 140,000 of them will pass away from the event. That makes stroke the fifth most common cause of death. These numbers speak volumes about our desperate need for new treatment options.

Silk Road Medical (NASDAQ: SILK), an innovative medical device company that came public in April, is on a mission to greatly reduce the risk of stroke and its devastating impact on society. Here's why it has a great chance at succeeding and could mint its shareholders a fortune in the process.

The problem: The vast majority of strokes are classified as "ischemic," which is when blood flow to the brain suddenly becomes blocked. A leading cause of ischemic stroke is carotid artery disease, which is the gradual buildup of plaque in the neck arteries that supply blood to the brain. If that plaque breaks away, it can travel up to the brain and cut off critical blood flow, triggering a stroke.

Read More: https://finance.yahoo.com/news/could-stroke-prevention-specialist-next-144100408.html

SUNNYVALE, Calif., Aug. 13, 2019 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK) (“Silk Road Medical”), a company focused on reducing the risk of stroke and its devastating impact, today announced the closing of a public offering of 4,200,000 shares of its common stock sold by selling stockholders, and the exercise in full of the underwriters’ option to purchase 630,000 additional shares of common stock from certain selling stockholders, at a public offering price of $39.50 per share. Silk Road Medical did not receive any proceeds from the sale of the shares of common stock by the selling stockholders.
​
J.P. Morgan Securities LLC and BofA Merrill Lynch acted as joint book-running managers for the offering. BMO Capital Markets and Stifel acted as co-managers for the offering.

Read More: https://www.globenewswire.com/news-release/2019/08/13/1901377/0/en/Silk-Road-Medical-Announces-Closing-of-Follow-on-Public-Offering-and-Full-Exercise-of-the-Underwriters-Option-to-Purchase-Additional-Shares.html

SUNNYVALE, Calif., Aug. 08, 2019 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK) (“Silk Road Medical”), a company focused on reducing the risk of stroke and its devastating impact, today announced the pricing of an upsized secondary public offering of 4,200,000 shares of its common stock by certain selling stockholders at a public offering price of $39.50 per share. In addition, certain selling stockholders granted the underwriters a 30-day option to purchase up to an additional 630,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. Silk Road Medical will not receive any proceeds from the sale of shares of common stock by the selling stockholders. The offering is expected to close on August 13, 2019, subject to the satisfaction of customary closing conditions.

J.P. Morgan Securities LLC and BofA Merrill Lynch are acting as joint book-running managers for the offering. BMO Capital Markets and Stifel are acting as co-managers for the offering.

Read More: https://www.globenewswire.com/news-release/2019/08/08/1899718/0/en/Silk-Road-Medical-Announces-Pricing-of-Upsized-Public-Offering.html

SUNNYVALE, Calif., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK) (“Silk Road Medical”), a company focused on reducing the risk of stroke and its devastating impact, announced today the commencement of a proposed underwritten public offering of 3,500,000 shares of its common stock by certain selling stockholders. In addition, certain selling stockholders expect to grant the underwriters a 30-day option to purchase an additional 525,000 shares of its common stock in the offering. Silk Road Medical will not receive any of the proceeds from the sale of the shares of its common stock being offered by the selling stockholders. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Read More: https://www.globenewswire.com/news-release/2019/08/06/1897999/0/en/Silk-Road-Medical-Announces-Proposed-Public-Offering-of-Common-Stock.html

Digital Care Leader's Integrated Program Supports Individuals Dealing with Chronic Disease, Mental Health Issues

SAN FRANCISCO, June 26, 2019 /PRNewswire/ -- Omada Health today announced a $73 million round of funding led by Wellington Management Company LLP. Wellington Management is an independent investment firm with more than $1 trillion of client assets under management. Omada will use the funding to fuel the continued expansion of its digital care program, including support for those with type 2 diabetes and hypertension, as well as those dealing with anxiety and depression.

Omada works with more than 600 employers and health plans across all 50 states, delivering an integrated experience that adapts to participants' health needs, and personalizes their journeys to create the best health outcomes. Omada's dedicated coaches guide each individual throughout the program, achieving unparalleled engagement and sustainable behavior change. Omada's proprietary coaching platform enables them to deliver personalized interventions at scale. The company proved the model for digital care as the nation's largest CDC-recognized provider of the National Diabetes Prevention Program, and has now launched programs over the last twelve months for diabetes self-management, as well as anxiety and depression, to holistically address individuals' health needs.

Read More: https://www.prnewswire.com/news-releases/omada-health-raises-73-million-to-accelerate-program-expansion-300874939.html