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CertaDose, Preparing to Sell First Product, Adds $5M and J&J Grant

Xconomy Texas — 

San Antonio — CertaDose, a medical device maker with a syringe that is meant to cut down errors when giving doses of drugs to children, has raised about $5 million in early stage funding and hopes to begin selling its first product this year.

CertaDose also announced in December a grant from Johnson & Johnson Innovation, which selected the company as the winner of a Quickfire Challenge for advancing safety in a healthcare product. The company was selected from an application pool of 100 companies to receive the $100,000 grant, and now gets access to office space at a JLabs facility in New York, and will receive mentoring from J&J executives, says CEO Larry Miller.

Founded by a Denver, CO-based emergency room physician, CertaDose applies a methodology of measuring drugs called the Broselow color system to a syringe, which CertaDose believes can help medical professionals better diagnose how much of a drug to give to a child in an emergency situation. The San Antonio, TX-based company received FDA clearance last year to use its syringe in delivering epinephrine, a hormone commonly used to respond to allergic reactions. So far, that’s the only drug for which it has clearance.

Epinephrine is famously used in EpiPens, the costly injectable made by Mylan Pharmaceuticals. CertaDose wants to compete with typical users of the EpiPen, such as emergency room doctors or paramedics, who need to keep the treatment on hand, and expects to charge about $90 for a kit that will include the company’s syringe and the drug, according to Miller. Mylan has received substantial criticism for price increases it made for EpiPens since it gained rights to sell them in 2007, charging upwards of $600 each, according to Reuters. Since the uproar, other companies have jumped into the market to introduce less costly generic versions.

CertaDose believes its syringes can compete because they make the standard system of measuring a dose for a child, color-coded Broselow tape, easier to use. Broselow tape is a physical product that helps medical workers determine how much of a drug dose a child should receive based on their weight. Children can’t take as much as adults—the larger dosage can be potentially deadly and small children can’t handle as much as bigger ones—and yet larger kids still need enough for the drug to be effective.

Doctors, nurses, EMTs, and other professionals use the tape to measure a child, and the color he or she registers gives the first indication of the dose they should receive. But the process still requires medical workers to make conversions (such as from pounds to kilograms, milligrams to milliliters) to deliver the right amount, Miller says. That can lead to errors when medical workers are drawing the appropriate dose of a drug into a syringe, particularly in fast-moving emergency situations. If a child needs 0.09 milligrams of a drug, how many milliliters do you draw into the syringe? Around 7,000 children die every year from medical dosing errors, the company says.

CertaDose says it’s product resolves that by placing the Broselow color scale directly onto the syringe, so that when a medical worker determines the weight of the child, they can merely draw to that color on the CertaDose syringe.

“It was so simple, but when I saw it, it was absolutely brilliant,” Miller says.

CertaDose’s Broselow color syringe was developed by Caleb Hernandez, who had discussed the idea with James Broselow, the creator of the color system. Hernandez bought the patent for applying the colors to a syringe from Broselow for cash—a fortuitous opportunity, since Broselow had previously already licensed most of the other patents, Miller says.

“The way you put the colors on [the syringe] is really important,” Hernandez says. “I found a way to do it so that you can keep the accuracy and do it the way the FDA likes.”

Now, CertaDose is working to bring its device to the market later this year and has already secured distribution deals, relationships that Miller first developed when he was at Vidacare, another medical device company he founded that sold in 2013 to Teleflex for $262.5 million. CertaDose also aims to gain approval to sell other versions of its syringe to be used for delivering around 20 more drugs, such as anesthesia medications (including midazolam and ketamine) and pain drugs, such as fentanyl. The company may seek a Series A round of funding this summer, Miller says.

The company closed its recent round of funding, which totaled around $5 million, in December. Miller says the money came primarily from private investors, including emergency room physicians, and medical liability insurance provider, Copic, which has offices in Denver and Lincoln, NE, and owns 33 percent of CertaDose, Miller says.

“That’s another validation about how important this system is,” he says. “They’ve had to pay out huge amounts for medical errors and dosing errors.”