|Zipline Medical's products can be applied with the speed of staples but offer the cosmetic outcomes of sutures.|
Amir Belson, one of the prolific medical device inventors in Silicon Valley, came up with the idea for a replacement for sutures while doing his residency in Israel. While doing an OB GYN rotation, Belson assisted in the delivery of a baby via C-section and was asked to suture the incision afterwards.
He thought: “This poor woman is going to hate her scar and she is going to blame the person who stitched her up,” recounts John Tighe, president and CEO of Zipline Medical (Campbell, CA). And as Tighe recounts it, Belson thought: “There’s got to be a better way.”
Belson later came to the United States with an idea for a replacement for the suture—along with 63 other device ideas on a piece of paper—to become one of the first fellows in Stanford’s Biodesign medical device engineering program.
He started Zipline in 2007 to develop a wound closure device called the Zip with a design so simple yet ingenious that one wonders why it wasn't invented in the past. It's basically tape with closures that tie it together. It can seal a wound so that it can heal, and can be peeled off later by the patient. It holds the wound together without puncturing it as staples and sutures do.
“The basic elevator pitch to a physician or surgeon is we provide the speed of staples with the cosmetic outcome of meticulous suture closure while also reducing the risk of infection,” Tighe says.
The Zip is a finalist in the Medical Design Excellence Awards, which will be awarded June 11 at a ceremony held in conjunction with MD&M East in New York.
“Surgeons say all of the time that they wish they would have invented this. The greatest ideas are simple ideas, and this is a simple idea.”
The Zip may be simple, but it also has unique, proprietary characteristics. (Zipline has three issued U.S. patents.)
“We use a proprietary hydrocolloid adhesive,” Tighe explains. “We use a series of nylon straps that create a dynamic compression. For example
s, when you put this on a knee, as you extend the knee and put more tension on the device, the incision actually gets pushed together. So we create some compression on the incision, which surgeons like.”
The company debuted its first product in June 2013 after something of a slow start.
“It was a true garage startup and virtual company,” Tighe says. “No money was put into the company until 2010, with the Series A. Amir was able to hire an engineer and some folks to get the thing going.”
Tighe himself joined in October 2011 after a gig as CEO of Peak Surgical, which was acquired by Medtronic that same year.
The company, which closed $4.3 million in Series C funding in January of this year, was able to bring in an in-house engineering team in 2012. Alan Schaer, the company’s vice president of R&D, oversees the company’s development efforts.
ZipLine Medical partners with Second Source Medical, a contract manufacturer based in San Jose that assembles the company’s products in a cleanroom. “They are sent out for sterilization and come back here, and we warehouse and ship everything in Campbell, CA.”
Tighe suspects the Zip has been attractive for investors partly because it has had a much simpler U.S. regulatory pathway than other devices. The Zip is Class I exempt device, which means we are exempt from having to do a 510(k).
|The winners of the Medical Design Excellence Awards will be announced in a ceremony held on June 11 in conjunction with MD&M East, June 9–12, 2014 in New York City.|
Revenue is ramping, with 45 active hospital customers. “Our main target market—at least where we have found initial traction—has been in orthopedics and also cardiology—specifically in electrophysiology for pacemaker and ICD implant cases,” Tighe says.
In a U.S. healthcare market in which controlling costs is becoming especially important amid pressure from both public and private insurers, the Zip has a strong value proposition because it eliminates the extra procedure time that can be taken up by suturing, according to Tighe.
“For a total hip or total knee, suturing can take 10 to 15 minutes to do the final skin closure. We take that down to about a minute,” Tighe says. From a managed care standpoint, that reduces labor costs and patient infection risks, not to mentioning eliminating the need for a return visit to remove staples or sutures.
That’s a promising sales pitch for a company seeking to break into what Tighe describes as a $4 billion wound closure market dominated by such giants as Johnson & Johnson, Covidien, and 3M Co.
“There are so many surgeries done and so many applications, I think the prospects for the company are very strong.”
Published in MPMN, May/June 2014, Volume 30, No. 3
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