Edward R Jones, MD, MBA, FACP LaRhondd James, RN Sophid Rosen, PhD
Ann Mooney MSN, RN, CNN Educardo Lacson, Jr., MD, MPH, FACP

Modalities of renal replacement therapy are categorized into in-center hemodialysis and home therapies. A subset of hemodialysis patients referred to as in-center self-care hemodialysis (ICSCHD) receive patient training as if they were going home but instead perform their dialysis in-center with minimal staff support. Preliminary data suggests ICSCHD is associated with better outcomes than traditional in-center hemodialysis. We looked at ICSCHD patients initiating maintenance dialysis from April 1, 2011 to March 30, 2014 and compared them at a 1:2 ratio to propensity-score matched controls from surrounding facilities within the same catchment area. The median follow-up was 14 months. Patients on ICSCHD had lower mortality rate (0.02 vs 0.07 per patient year; p <0.05), fewer hospitalization events (0.82 vs. 1.70 per patient year; p = 0.008) and fewer missed treatments (1.1% vs 3.8% of all treatments; p = 0.005) than matched controls. We concluded that patients on ICSCHD had lower mortality rates and fewer hospital days than well-matched controls and spent more time on dialysis and missed fewer treatments. Establishing a facility-wide culture of care promoting patient engagement in ICSCHD may have contributed to these findings.

Read More: http://www.nephrology-digital.com/September2016/Default/15/0?token=B59Z96FC30M2ZXKN

Results Expected in the First Half of 2017

REDWOOD CITY, Calif., Sept. 01, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical development-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced the completion of patient enrollment of 207 patients in the randomized Phase 2 "YOSEMITE" clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of first-line metastatic pancreatic cancer.  Topline results are expected in the first half of 2017.

The YOSEMITE trial was designed to assess the efficacy and safety of demcizumab in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine (standard of care) compared to standard of care alone.  The Phase 2 dose of demcizumab was 3.5 mg/kg every two weeks for up to 70 days.  The primary endpoint of YOSEMITE is progression-free survival.  Secondary and exploratory endpoints include overall survival, response rate, pharmacokinetics, immunogenicity, safety and biomarker analyses.  Patients enrolled in the YOSEMITE Phase 2 were randomized into one of three study arms receiving 1) standard of care plus one course of demcizumab, 2) standard of care plus demcizumab followed by a second course of demcizumab after a 98-day wash-out period or 3) standard of care plus placebo.  The YOSEMITE Phase 2 trial was conducted at 49 clinical sites in the U.S., Europe and Australia.  OncoMed initiated YOSEMITE in April 2015.

Read More: http://investor.shareholder.com/oncomed/releasedetail.cfm?ReleaseID=987441

NN&I interviewed Leslie Trigg, CEO of Outset Medical, on the company's new Tablo dialysis machine, which is aimed at clinics who want to develop the self-care option for patients.

NN&l: What are Tablo's key attributes?
LESLIE TRIGG: The Tablo technology is aimed at meaningfully improving the care experience for patients and lowering labor, infrastructure, and clinical costs for providers. In dialysis clinics, this comes in the form of in-center self care in which patients are able to set up and manage their Tablo treatments independently. 

Three key Tablo technology innovations enable this approach: consumer product design simplicity, integrated water purification with dialysate production on demand, and wireless medical informatics.

NN&l: Why is the Tablo a good fit for in-center self-care?
TRIGG: We've stayed very focused on minimizing the number of set up steps, eliminating memorization and mental math, and building a user experience to ensure it is accessible. In the clinic, that's translated into Tablo training times measured in single-digit hours, not weeks, and fast set up times that allow for self care to fit well into the clinic's existing workflow.

Read More: http://www.nephrology-digital.com/September2016/Default/19/0?token=B59Z9LXJFKB91GG7

By: Sarah S. Prichard, MD, FRCP(C) Glenn M. Chertow, MD, MPH

Conventional in-center hemodialysis is the modality used by approximately 90% of patients receiving dialysis in the U.S. For patients and providers, there are clear disadvantages to conventional in-center HD therapy. The current alternative is to use a home-based self-care modality, either home hemodialysis or peritoneal dialysis. These home-based selfcare modalities have been shown to have a number of advantages, but are not widely adopted for a variety of reasons. Another option would be to offer in-center self-care HD, which could provide many of the advantages of home-based dialysis, and remove many of the barriers that prevent patients from choosing to do dialysis at home.

Read More: ​http://www.nephrology-digital.com/September2016/Default/13/0?token=B59Z8BHS4SN4JB12

Innovator: Leslie Trigg
Age: 45
Chief executive officer of Outset Medical, an 85-employee company in San Jose

Form and function
Tablo is a 150-pound, 3-foot-tall, largely automated dialysis machine designed for patients to use by themselves, with a simple step-by-step procedure that makes it easier to operate than existing home machines.

Origin
Outset was founded as Home Dialysis Plus in 2003 with technology licensed from HP and Oregon State University and developed by co-founder Michael Baker.

Funding
Outset has raised more than $100 million, plus $40 million in debt financing, from investors including Warburg Pincus and Fidelity Investments.

Market 
About 460,000 U.S. patients have end-stage kidney diseases that require help from dialysis clinicians, typically three times a week.

Early use
Outset says testers age 29-79 were able to prep the dialysis machine for use in 10 to 12 minutes with minimal training.

Read More: http://www.bloomberg.com/news/articles/2016-08-17/a-self-serve-dialysis-machine-may-be-coming-home-with-you

MedtechVision 2016: Global Medtech

On September 13th, Medtech Vision will host the sixth annual MedtechVision conference. This year’s interactive discussion will focus on Global Medtech.

Increased focus in the medtech industry on OUS markets in recent years has led to exciting innovation and evolution in product development, commercialization models and even funding strategies. MedtechVision2016 explores opportunities for medtech to continue to thrive globally.

Erica Rogers, President and CEO of Silk Road Medical, will speak during the Executive Interview portion of the conference. 

Read More: http://medtechwomen.org/events/medtechvision-2016-global-medtech/

Last week, Omada Health, a San Francisco digital health startup, announced that it is partnering with the American Medical Association and Intermountain Healthcare, the Salt Lake City, Utah-based health system, to prevent the onset of diabetes in adult patients.

It marks the first time that the American Medical Association has announced a formal partnership with a digital health company, a development that was news in itself.

But it’s also important to review why Intermountain Healthcare, the largest private employer in the state of Utah, chose to go the digital route in preventing its prediabetes patients from developing full-blown type 2 diabetes.

Read More: http://medcitynews.com/2016/08/intermountain-chose-omada-health-provide-diabetes-prevention-services-patients/