EasyDial Inc., a maker of kidney dialysis devices, has boosted its employment base in anticipation of a Food and Drug Administration approval and a move to Irvine from Laguna Hills.
The company now has 67 employees spread among Laguna Hills and four U.S. branch offices, up from six workers just six months ago.
Kidney dialysis makes up a large global market. Dublin-based tracker Research & Markets estimated its value at $69.5 billion last year.
EasyDial’s primary device is the Dharma, which is intended to cut the time patients spend on dialysis from the traditional four- to six-hour period to two hours. It’s a portable machine that weighs 18 pounds, including its carrying case, and has Federal Aviation Administration approval for overhead compartment storage.
The microprocessor-controlled device is designed with separate circuits for the dialysate solution and water, thereby reducing medical waste.
“[We are] fully dedicated to and committed to the redesign of dialysis equipment,” said Renato Giordano, EasyDial’s chief executive, during an interview late last month at the company’s Laguna Hills office.
He noted that the company’s treatment design allows for in-home use and can return dialysis patients to “a possible kind of life” that Giordano said “with today’s treatment, the way the treatment is done in clinics, is not achievable.”
He meant that patients can continue with their lives as normal, including business travel.
The company is preparing documents for an FDA submission, and Giordano said EasyDial hopes to get approval by the end of the year.
EasyDial is pre-revenue and “not selling overseas until we get through clinical trials,” said Chief Financial Officer Aaron Mishkin.
The company “proudly can tell you we started this on our own nickels and monies, family and friends,” along with the principals’ pension funds, Giordano said.
EasyDial considers clinic providers such as Denver-based DaVita HealthCare Partners Inc. and Plano, Texas-based U.S. Renal Care Inc. as potential customers, along with nephrologists, who are doctors that treat kidney disease.
“DaVita is a service provider and could possibly be a major customer,” Giordano said.
Large companies that make dialysis machines include Chicago-based Baxter International Inc., which employs 300 in Orange County, and Germany-based Fresenius SE& Co. KGaA.
EasyDial plans to move to its new building in the Spectrum Tech Center at the end of the month, Giordano said. The 11,000-square-foot building will include cleanrooms, research and development, and engineering quality functions. The company’s Laguna Hills office, which has about 2,000 square feet of space, will become its doctor training center.
Patients will have to get a prescription to obtain the device, and their doctor will train them on how to use it on their own.
Giordano, an electronic engineer by trade, mentioned a personal experience as a reason behind establishing EasyDial.
“I was on dialysis for a little bit” after surgery, he said. He mentioned that going to clinics for dialysis affected his quality of life, including time he spent with his family and having to cut back on travel.
Giordano previously worked with the Italian air force in designing communications and navigation systems. He and other engineers designed Dharma.
“Dialysis is not really a cure. It’s a sustaining procedure [to] stay alive,” he explained, noting that kidney disease patients usually wait nine to 11 years for a transplant.
Patients typically stay on dialysis machines for seven to eight years before complications develop, he said.
In addition to the Laguna Hills location, EasyDial operates a Costa Mesa shop that handles tooling and parts for production, a software development office in Indiana, a laboratory in San Diego that the company is considering relocating to Irvine, and an international office in Italy.
