Outset Medical’s Tablo System combines consumer product simplicity, wireless connectivity and real-time integrated water purification to create a 35-inch dialysis clinic on wheels. Tablo has been cleared by the U.S. Food and Drug Administration (FDA) for use in acute and chronic care settings such as dialysis clinics and hospitals.
The company plans to use the financing to launch the product this year and pursue expanded FDA clearance to allow patients to use Tablo at home. The FDA approved an investigational device exemption (IDE) trial to evaluate the safety and efficacy of Tablo in this setting.
“We are gratified by the strong showing of support from existing and new investors who share our vision of expanding where, how and who can perform hemodialysis,” said Leslie Trigg, Outset Medical CEO. “Today, hemodialysis is labor-intensive and expensive to provide, and many patients lack flexibility and control over the experience. Tablo enables new care delivery models that may offer significant cost reduction opportunities for providers while substantially improving the experience for patients.”
Dialysis is delivered several times per week to remove waste products and excess fluid from kidney failure patients. With 460,000 patients in the United States dialyzing at least three times per week, more than 72 million dialysis treatments take place each year, industry data show. According to the 2011 United States Renal Data System, the annual cost of dialysis to Medicare exceeds $34 billion.
“Dialysis is a life-sustaining therapy that has changed very little in the last few decades,” said Glenn M. Chertow, M.D., Norman S. Coplon/Satellite Healthcare professor of Medicine and chief of the Division of Nephrology at Stanford University School of Medicine in California. “I am excited about the ways Tablo can offer expanded choices for dialysis patients. Many patients who receive dialysis want more control over the experience and want to live fuller, more independent lives. These patients are extremely capable, and with improved technology, could take the lead in their own dialysis care with minimal assistance. Other areas of medicine suggest that when people are directly engaged in their care, they live longer and feel better.”
Outset Medical’s Tablo System turns a complicated process into one patients can master through consumer product design and technology automation. Designed to look and feel more like a consumer product than a medical device, Tablo’s small size, color and form factor are intended to minimize patient apprehension and build confidence and competence, company bigwigs said. Automation dramatically reduces the time involved in setting up and managing dialysis whether in the clinic or at home. For example, the system requires less than half the number of set-up steps compared to incumbent dialysis machines. The user engages with Tablo through a touchscreen that offers step-by-step 3-D animation and conversational instructions that enable a self-guided, customized experience.
Tablo removes the need for expensive clinic infrastructure, the company added. The system connects to tap water and purifies it on demand. Tablo also generates dialysate (dialysis solution) in real-time while the patient is dialyzing. By disconnecting dialysis from expensive “bricks and mortar” infrastructure, Tablo expands the settings in which dialysis can be efficiently delivered.
At the end of treatment, Tablo transmits clinical data wirelessly to care providers. This connectivity streamlines a process that historically has been manual, time-consuming and costly.
“As the first institutional investor in Outset, we have been thrilled with the company’s progress in bringing Tablo through key development milestones,” said Noah Knauf, managing director at Warburg Pincus. “Outset’s management team and our investor group position the company to transform the experience of dialysis care.”
Chronic kidney disease (CKD) can be caused by diabetes, high blood pressure and other disorders, and affects approximately 26 million Americans. The condition is divided into five stages. The most advanced stage of CKD is known as kidney failure or end-stage renal disease (ESRD). Unless patients receive a kidney transplant, patients with ESRD require dialysis treatments several times each week to eliminate waste products and excess fluid from the blood.
Outset Medical is dedicated to reimagining the experience of dialysis care for patients with kidney disease. The company is located in San Jose, Calif., and is backed by Warburg Pincus, Fidelity Research and Management Company, Perceptive Advisors, Partner Fund Management LP, The Vertical Group and CRG.