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.
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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
Via: PR Newswire
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.
FreeStyle Libre's glucose readings, trends and patterns will all be incorporated into Omada's app.
Alongside a deeper collaboration with the not-for-profit system, Omada expects the funds to fuel expansion of its integrated digital care program.
Via: Carilion Clinic
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.”
Via: Yahoo! Finance
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 Announces Closing of Follow-on Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares
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.
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.
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.
Via: PR Newswire
Digital Care Leader's Integrated Program Supports Individuals Dealing with Chronic Disease, Mental Health Issues