Serial entrepreneur Bill Colone, who has extensive experience with medical device companies, wanted to improve the safety of biopsy procedures.
He eventually teamed up with a business partner and two doctors to form Single Pass in Orange County in 2020. It's named Single Pass because Colone claims it only requires a “single pass” with the company’s device to perform a biopsy and prevent bleeding after the procedure.
The startup, headquartered in Lake Forest, is part of the more than $2 billion-and-growing biopsy device market.
Foundation
Colone first got the idea for the company after he was introduced to two radiologists, who routinely perform four to five biopsy procedures a day.
"Over their years of experience, the physicians noted that they did not have any techniques or tools that allowed them to fully control the safety of biopsy procedures," he told L.A. Inno. "As a result, patients occasionally needed additional procedures, sometimes invasive surgery or long hospital stays, due to the damage caused by the biopsy tools. Although uncommon, patients may also suffer severe hemorrhage, or even die after bleeding complications."
So Colone and his business partner, Dave Ferrera, along with the two radiologists, Peter Sunenshine and Kevin Hirsch formed Single Pass. Fundraising efforts began in Spring 2021.
Funding
The co-founders initially put in more than $200,000 of their own money, Colone said. They got subsequent funding from angel investment groups, individual angel investors and other physicians.
In total, the company has raised more than $3 million from seed and Series A rounds. It may open a Series B round in late Q2 or early Q3 to fund its commercial launch, Colone said. The target would be about $5.5 million.
The company is in the pre-commercial stage. It has finished R&D and has the final configuration of the device it will bring to market, Colone said.
The team has completed its clinical study and plans to submit the device for FDA approval this month.
It's all about heat
Single Pass created an electro-cautery device. Cauterization is a technique of burning tissue to remove, or close off, a part of the body.
It's a disposable device that can cauterize deep tissue through a needle.
Two batteries in the handle provide current to the tip of Single Pass' probe to "super heat" it. That heat seals, or cauterizes the tissue, to prevent bleeding, Colone said.
Serial entrepreneurs
The co-founders and technical team members have previously launched six medical device companies. Half of them have been acquired. Endomed was acquired by LeMaitre Vascular in 2005 for cash and equity. MindFrame was acquired by Covidien for $75 million and Blockade was sold to Balt for $42.5 million.
The previous endeavors provided valuable experience, Colone said, “on everything from fundraising to talent acquisition to attracting strategic partners.”
Benefits of being in OC
The Orange County area has a “rich talent pool,” Colone said, due to Edwards Lifesciences, a global med-device company, being headquartered there, along with the local offices of other industry leaders like Medtronic, Stryker and Johnson & Johnson.
As Colone is the sole full-time employee of the company, the design and development work, along with product manufacturing, is performed by local company M4D.
Competition
Single Pass has obtained multiple patents, Colone said.
The most similar competitor is Bovie, named after its founder, William Bovie, a physicist who invented a high-frequency electro-surgical device for cutting and cauterizing tissue.
Although the Single Pass device is sometimes referred to as “a Bovie for biopsy,” Colone claims that "no other electro-cautery devices can be used for biopsy procedures, due to the inability of their heated probe to fit inside a biopsy guide needle."
