Outset Medical announced it received $76.5 million in Series C equity funding. A new investor, funds advised by T. Rowe Price Associates Inc., led the round, which also included participation from existing investors Fidelity Management & Research Company, Partner Fund Management LP, Warburg Pincus, Perceptive Advisors and The Vertical Group.

Outset’s technology, the Tablo Hemodialysis System, is aimed at clinics who want to develop the self-care option for patients. It can also be used in hospitals and skilled nursing facilities.

The company will use proceeds from the financing to expand the commercial introduction of the Tablo System in acute and chronic care markets in the United States.

Read More: ​http://www.nephrologynews.com/outset-medical-gets-financing-expand-introduction-tablo-dialysis-machine/

Financing to Expand U.S. Commercial Introduction and Manufacturing

SAN JOSE, Calif.--(BUSINESS WIRE)--Outset Medical, a commercial-stage company delivering first-of-its-kind technology into the $13 billion global dialysis market, today announced $76.5 million in Series C equity funding. A new investor, funds advised by T. Rowe Price Associates, Inc., led the round, which also included participation from existing investors Fidelity Management & Research Company, Partner Fund Management LP, Warburg Pincus, Perceptive Advisors and The Vertical Group.

Outset’s technology, the Tablo™ Hemodialysis System, is the first novel dialysis system to reach the U.S. market in more than 15 years. The system can be used flexibly across a range of clinical settings from dialysis clinics to hospitals and skilled nursing facilities. The company will use proceeds from the financing to expand the commercial introduction of the Tablo System in acute and chronic care markets in the United States.

Read More: http://www.businesswire.com/news/home/20170503005383/en/Outset-Medical-Announces-76.5-Million-Funding-Innovative

I heard Omada Health president Sean Duffy on an April 13, 2017 NEJM Catalyst webinar reference the road by which non-pharmacological, integrative diabetes care gained coverage. Duffy, a “high tech high touch” Bay Area entrepreneur, displayed his literally out-of-the-box thinking elsewhere in the webinar when he urged the medical industry to “build a pervasive culture in which in-person visits are a last resort.” Might this interesting executive’s experience offer insights for those who realize that lack of coverage for non-pharmacologic, integrative pain treatment is a massive barrier to human health? I set up an interview.
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First, however, I looked into the Diabetes Prevention Program (DPP) that Duffy said provides the data foundation for Omada’s now 50-state program. The 2002 DPP study compared a multi-modal integrative diabetes strategy - diet, physical activity and behavior modification - with the drug Metformin. The integrative arm performed with such success that research was halted early so public benefit could immediately commence.

Read More: www.huffingtonpost.com/entry/omada-healths-duffy-on-integrative-diabetes-coverages_us_57910576e4b0a1917a6e3e06

Extends Projected Cash Runway through Q3 2019 to Focus on Clinical-Stage Programs and Immuno-Oncology Discovery and Development

REDWOOD CITY, Calif., April 24, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, announced today a significant reduction in its workforce to focus internal efforts on the advancement of three clinical-stage programs to key milestones and continued immuno-oncology drug discovery and development, while seeking to partner select pipeline assets. 

OncoMed will reduce its workforce by approximately 50 percent, resulting in 64 remaining full-time employees.  Through implementation of the plan announced today, OncoMed expects to realize significant cost savings of approximately $60 million over the next two years associated with personnel and operating expenses.  The company anticipates having sufficient cash to fund operations through Q3 2019, excluding any revenue generated from existing partnerships or potential new partnering arrangements. 
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Read More: http://www.oncomed.com/invest/releasedetail.cfm?ReleaseID=1022595

REDWOOD CITY, Calif., April 17, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today reported top-line results from the company's randomized 145-patient Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide plus either cisplatin or carboplatin chemotherapy ("chemotherapy") in previously untreated patients with extensive-stage small cell lung cancer.  Results for the combination of tarextumab plus chemotherapy were undifferentiated from those of chemotherapy plus placebo, and therefore the trial did not meet its primary endpoint of progression-free survival or secondary endpoints of overall survival and biomarkers reflective of Notch pathway gene activation.

"Small cell lung cancer is a very difficult-to-treat disease and unfortunately, tarextumab did not show benefit over placebo in this Phase 2 trial," said Paul J. Hastings, OncoMed's Chairman and CEO.  "We deeply appreciate the participation by the investigators and staff, patients and caregivers who all contributed to the conduct and completion of this Phase 2 clinical trial."

OncoMed also announced today that it will discontinue enrollment in the Phase 1b clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) in combination with trifluridine/tipiracil (Lonsurf®) in third-line colorectal cancer patients.  The combination of brontictuzumab plus chemotherapy was not tolerable in this patient population.

Read More: http://www.oncomed.com/invest/releasedetail.cfm?ReleaseID=1021452

Complex aortic arch configurations and internal carotid artery (ICA) tortuosity were bad news for carotid artery stenting, but not endarterectomy, according to an MRI substudy of the International Carotid Stenting Study (ICSS).

New ischemic brain lesions on diffusion-weighted MRI after treatment were found in 51% of cases after stenting and 16% of cases after surgery (OR 6.0, 95% CI 2.9-12.4), the paper in the May 2017 issue of Stroke showed.

With carotid artery stenting, Leo Bonati, MD, of University Hospital Basel in Switzerland, and colleagues found age-independent predictors for new brain lesions to be aortic arch configuration type 2 or 3 (OR 2.8, 95% CI 1.1-7.1) and an ICA angle of 60º or higher (OR 4.1, 95% CI 1.7-10.1).

Those whose largest ICA angle was at least 60º had a 12-fold higher risk of strokes during stenting over their peers with smaller ICA angles (OR 11.8, 95% CI 4.1-34.1).

Read More: ​​https://www.medpagetoday.com/cardiology/atherosclerosis/64568

Forrest General Hospital became the first hospital in Mississippi to use the transcarotid artery revascularization method of carotid stenting on Feb. 27.

The procedure was performed by Edgar Guzman, MD, FACS, RPVI, vascular surgeon at Forrest General Hospital.
TCAR is a new treatment option for carotid artery disease that prevents stroke during the procedure by temporarily reversing blood flow in the carotid artery. This prevents debris from traveling to the brain and causing a stroke. During the procedure, physicians implant a stent to treat the blockage and lower the patient’s risk of future stroke. After the stent is placed successfully to stabilize the plaque in the carotid artery, flow reversal is turned off and blood flow to the brain resumes in its normal direction.

“In this particular case, the patient had a previous surgical reconstruction and abnormalities of the blood vessels making traditional carotid stenting impossible," said Guzman. "TCAR allowed the team to overcome both issues, while at the same time reducing the risk of stroke via reversal of flow in the carotid artery. At the end of the procedure, the filter in the system had captured significant debris that would have caused a stroke had they reached the brain."

Read More: http://www.hattiesburgamerican.com/story/news/local/2017/04/12/fgh-becomes-first-state-perform-tcar-procedure/100391240/

ALBUQUERQUE, N.M. — Dudley Sue Bock, 75, received the shocking news last July that she had a 70 percent blockage in one of the two arteries that provide blood to her brain.

In October, Bock became one of the first patients in the Southwestern U.S. to undergo a new stenting procedure at New Mexico Heart Institute that restored blood flow through carotid artery on the right side of her neck.

The procedure, called Transcarotid Artery Revascularization, or TCAR, is intended to lower the risk of stroke or heart attack, particularly in older patients, while patients are on the operating table, Heart Institute surgeons said.

“The question here is, is there any way to limit that stress on the heart, but keep the procedure as safe and effective” as conventional surgery, said Dr. Steve Henao, the Heart Institute’s chief of vascular surgery.

The Heart Institute is one of about 40 medical centers worldwide participating in a study to evaluate the effectiveness of TCAR, which was approved by the U.S. Food and Drug Administration in 2015 for use in patients at high risk of stroke.

Read More: https://www.abqjournal.com/981104/technology-3.html

Anti-TIGIT Demonstrates Potent Anti-Tumor Activity in Preclinical Models

WASHINGTON and REDWOOD CITY, Calif., April 03, 2017 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, presented data from multiple preclinical studies detailing the mechanism and anti-tumor activity of anti-TIGIT alone and in combination with checkpoint inhibitors at the AACR Annual Meeting 2017.  These are the first data from OncoMed's anti-TIGIT program to be shared publicly.  OncoMed plans to initiate a Phase 1a single-agent study of its anti-TIGIT antibody (OMP-313M32) in the first half of 2017.
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"TIGIT is a highly desirable target in immuno-oncology with similarities in structure and function to PD1 and broad expression of its ligands on a wide variety of tumor tissues. We believe that by blocking TIGIT signaling our anti-TIGIT antibody may enable T-cell activation and facilitate a potent anti-tumor immune response, potentially halting the growth and recurrence of tumors," said Austin Gurney, Ph.D., OncoMed's Senior Vice President of Molecular and Cellular Biology and co-Chief Scientific Officer.  "In multiple preclinical studies with anti-TIGIT antibodies we have observed immune activation and robust anti-tumor activity — both as a single agent and in combination with other cancer immunotherapeutics.  Notably, the effect on inhibiting tumor growth persists upon re-challenging cured animals with re-injection of tumor cells, indicating that we are inducing a long-term immune memory response that we hope will translate into long-term clinical benefit.  We look forward to advancing our anti-TIGIT antibody into the clinic in the first half of 2017."

Read More: http://www.oncomed.com/invest/releasedetail.cfm?ReleaseID=1019847

Outset Medical, a commercial-stage company delivering new technology into the $13 billion global dialysis market, today announced the appointment of Gus Castello as the company’s chief operating officer.

Gus is an experienced med tech veteran with more than 30 years of diverse leadership positions in product operations and quality. From early 2002 until late 2013, he held the positions of Vice President of Manufacturing and later, Senior Vice President of Product Operations worldwide for Intuitive Surgical, Inc. (ISRG). During Gus’ tenure at Intuitive Surgical he was responsible for the leadership, planning and execution of the company’s Product Quality and Operations strategy in support of 20% year-over-year topline revenue growth from $40 million in 2001 to $2.3 billion in 2013. During this time, Gus also led key initiatives around the reliability, cost reduction and high-volume manufacturability of four generations of the da Vinci ® Surgical System and its associated surgical tools and accessories.

“We are thrilled to welcome Gus to the Outset Medical leadership team,” said Leslie Trigg, Outset Medical’s CEO. “In much the same way Intuitive Surgical leveraged technology to transform the way surgeries are performed, Outset sees an opportunity for new technology to reduce the cost of dialysis care and meaningfully improve the patient experience. Gus’ experience helping build Intuitive Surgical into the powerhouse it has become is invaluable as we scale the growth of our technology both domestically and abroad.”

Read More: ​http://finance.yahoo.com/news/outset-medical-announces-appointment-gus-181200197.html