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Scaling Up: Aliso Viejo’s Okami Medical Inc.

Upstart Device Maker Okami Medical, With New CEO, Aims to Follow in Footsteps of Inari Medical

Rhonda Robb’s 25-year career in the medical device industry includes an executive position in the heart valve division of industry giant Medtronic PLC (NYSE: MDT), as well as holding the chief operating officer role at another cardiovascular-focused firm that was sold for almost a billion dollars last year.

Now Robb is taking a big leap by moving from Minnesota to a little-known Aliso Viejo device maker that’s developing new types of cardiology treatments.

Okami Medical Inc., a maker of products to control blood flows to arteries, counts 30 employees and has yet to commercialize its first product.

While small now, it has a backer that’s responsible for one of Orange County’s biggest success stories in the medical device industry of late, Irvine-based Inari Medical Inc. (Nasdaq: NARI), while its chairman, Robert Rosenbluth, has helmed several other large device makers in the area.

Okami earlier this month named Robb as its chief executive, with an eye on taking the company’s products to market.

“I really liked the idea of working for a startup company, and Okami’s technology and people were very compelling to me,” Robb told the Business Journal.

2022 FDA Nod

Okami, founded in 2017, says its products are designed to “address key unmet clinical needs in peripheral vascular intervention,” a type of cardiology treatment that’s focused on blood vessels outside the heart.

The company is aiming to commercialize its LOBO Vascular Occlusion System, which received 510(k) clearance from the Food and Drug Administration in June 2022.

Okami’s LOBO system stands for low-profile braided occluder. The device is made up of barely visible, braided wires that are one-fourth of the thickness of a human hair.

Surgeons use occluders to obstruct or reduce the rate of blood flow to arteries during operations commonly done on patients with an embolism or aneurysm.

Robb said there are broad potential uses for the LOBO system, ranging from hemorrhage control to patients with cancer, as well as women’s health. The company’s system is currently attracting attention from interventional radiologists that specialize in minimally invasive procedures, she said.

“I hope that this becomes the standard of care for patients with vascular conditions,” Robb said.

Okami expects to commercialize LOBO in the U.S. first and then Europe, with plans to expand its portfolio with “two specialized catheter delivery systems that will make LOBO even easier to use,” according to Robb.

Fox and the Wolf

Robb succeeds Okami founder Rosenbluth, who will retain his post as chairman of the board.

Okami is the second portfolio company of medical device company incubator Inceptus Medical LLC, an Aliso Viejo-based firm started by Rosenbluth.

Inceptus in 2013 spun out its first portfolio company, Inari Medical, which makes devices to remote blood clots in the veins.

Inari went public in 2020 at $19 a share. Its stock currently trades around $57, giving it a market cap close to $3.3 billion.

Both companies also share ties to Japanese culture; Inari is the Japanese deity of foxes, while okami means wolf.

Prior to Inceptus, Rosenbluth was a founder and CEO of Aliso Viejo’s Sequent Medical, a maker of products to treat brain aneurisms, which was acquired by Terumo Medical in 2016 for $380 million.

Before Sequent, he was a founder of MicroVention, a neuroendovascular medical device maker now with a large base in Aliso Viejo and also owned by Terumo.

“We are thrilled to have her leading the company into the next phase of expansion and growth,” Rosenbluth said in a statement. “Rhonda brings a proven track record and a wealth of experience to the company.”

Edwards Competition

Robb’s 25 years in the industry includes vice president and general manager for heart valve therapies at Medtronic, where she led the transcatheter and surgical heart valve franchises for the $114 billion-valued firm.

During her early days at Medtronic, Robb said she helped grow the company’s transcatheter aortic valve replacement business to over a billion dollars.

That Medtronic unit is the largest competitor to Irvine’s Edwards Lifesciences Corp. (NYSE: EW), OC’s second-most valuable public company, with a market cap of $45 billion.

After Medtronic, Robb went on to become COO of Cardiovascular Systems Inc., a 725-employee company best known for minimally invasive treatments for plaque build-up in arteries. Robb expanded the portfolio to more than 20 products; it reported 2022 fiscal year revenue of $236.2 million.

Last year, the St. Paul, Minn-based company was acquired by Abbott Laboratories for $890 million.

Robb also serves on the board of directors for 4C Medical Technologies Inc., a Minnesota company focused on developing therapies for structural heart disease.

Robb, who will be commuting back and forth between Minnesota and California, said she plans to spend her first few weeks at Okami getting to know the company and its employees.

“The company is small enough where I have the blessing to be able to meet with every single employee and look at our goals,” Robb said.

Priorities

One of Robb’s first priorities is to determine which infrastructures in the company, such as sales or manufacturing, need to be built out to better prepare for commercialization.

Okami is in the early planning stages of potentially hiring more field representatives at its Aliso Viejo headquarters and across the country.

“The team has done a tremendous job of taking the system from the conceptual stage through clinical validation,” Robb said at the time of her appointment as CEO.
Funding will also be on Robb’s agenda.

She said Okami will open fundraising to investors to support the launch of LOBO in the United States.

The company recently raised $6.1 million, according to regulatory filings. Prior to that, it raised a reported $7.5 million in 2021.

Two Inari Medical directors also serve as directors for Okami, including Inari chairman Donald Milder, the co-founder of VC firm Versant Venture Management, regulatory filings indicate.

Inari Sales Up, Eyes Profitability

Inari Medical Inc. (Nasdaq: NARI) this month reported preliminary fourth-quarter revenue to be at least $132 million, a 22% increase from the year prior.

Sales for the full year of 2023 are expected to climb 29% to $493.5 million for the Irvine-based device maker, surpassing analysts’ estimates.

Inari said it expects full year 2024 revenue of $580 million to $595 million, reflecting growth of about 17.5% to 20.5% over 2023.

The company, which employs over 600 people in Orange County, makes products to remove blood clots from veins.

Inari Chief Executive Drew Hykes in a Jan. 9 statement said the company is “progressing towards operating profitability.”

The company said it “now expects to reach sustained operating profitability in the first half of 2025, versus the prior forecast for sustained operating profitability in the second half of 2025.”

Inari, currently valued around $3.3 billion, made its largest ever acquisition in November when it paid $415 million to acquire LimFlow, a company that helps patients avoid amputations.

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