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Single Pass Gets FDA OK for Kronos Biopsy Device

Single Pass Inc.’s Kronos Electrocautery device hit the U.S. market last Wednesday.

The Lake Forest-based medical device maker said on April 29 that it received clearance from the Food and Drug Administration for its single-use biopsy closure device which aims to prevent bleeding after procedures.

The FDA approval comes five months after the company received clearance in the European Union.

“Our company is only [3 years] old, so it’s really fast to have both the CE mark and FDA clearance in that short of a time frame for a brand-new medical device company,” co-founder and Chief Executive Bill Colone told the Business Journal.

Single Pass, founded in 2021, has raised around $4.5 million to date from investors including TCA Venture Group, NewFund Ventures and Kyto Technologies.

Distribution Partnerships

Single Pass launched Kronos with its exclusive U.S. distributor Mermaid Medical Group, a global provider of medical devices based in Denmark.

The company last month also announced an exclusive international distribution deal with Michigan-based 3comma Medical / 3comma Medical GmbH.

Colone said 3comma is experienced with helping early-stage medical companies in the U.S. get into the European market.

These partnerships are part of the company’s business model of outsourcing most of its work from third parties.

“We mostly rely on relationships with service vendors,” Colone said.

Colone said that he is one of two employees at Single Pass and credits its outsource model with Kronos receiving FDA clearance within six months of submitting.

“We do not have to buy a facility or rented facility, build a cleanroom, add employees or build a quality management system,” Colone said. “The day we signed with our contractors, all that’s in place.”

Single Pass employs a contract manufacturer located across the street from its headquarters called M4D LLC, a 60-employee company that handles the design, testing and regulatory submissions.

“I really think that takes anywhere from six months to a year and probably a million dollars off the budget if you do the business model the way we do it,” Colone said.

Exit Plans

Single Pass has sold 500 units of the Kronos device in Europe, according to Colone.

“Between the clinical study and the early commercial usage, the feedback has been wonderful,” Colone said.

Now that Single Pass has secured both FDA and CE clearance, Colone said “there’s a very high probability that we will exit before the end of this calendar year.”

The company has already hired a registered broker and is in talks with potential buyers, but has received no official offers yet.

“As a single product company, it’s really hard to raise enough money to develop a salesforce that can pay for itself, so when we started this company, we had the exit in mind,” Colone said.

In the meantime, Single Pass will focus on its global commercial launch and soon enroll patients in a clinical registry to collect more data based on real life cases.

“We hope both of those being positive will lead to the company exiting this year,” Colone said.

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Sonia Chung
Sonia Chung
Sonia Chung joined the Orange County Business Journal in 2021 as their Marketing Creative Director. In her role she creates all visual content as it relates to the marketing needs for the sales and events teams. Her responsibilities include the creation of marketing materials for six annual corporate events, weekly print advertisements, sales flyers in correspondence to the editorial calendar, social media graphics, PowerPoint presentation decks, e-blasts, and maintains the online presence for Orange County Business Journal’s corporate events.
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