There was no history of breast cancer in Kate Dilligan’s family. So when she learned she had it, back in 2016, she was suddenly thrust into a world of surgery and treatment that would dictate her life for the next 10 months.
She soon found that there was no easy way to prevent hair loss. So she started working to create one.
Her invention, a portable cooling device, recently received FDA clearance. Look for it to hit the market this Spring at selected medical centers.
As a female founder, she credits the network she amassed from working in tech, along with various SoCal accelerators for giving her the boosts she needed.
Her startup, Cooler Heads, is preparing for commercial launch — building inventory from its most recent funding round, which was oversubscribed, and developing its e-commerce presence so it can lease the device to patients with a prescription.
And, she’s been recognized for her innovation in several startup competitions, most recently by the Ignite Healthcare Network.
Before starting her own company, Dilligan worked for more than a decade for a company that developed software systems for the federal government. Unfortunately, this company succumbed to the challenge of trying to build its own ASIC and software systems. (ASIC is an acronym for application-specific integrated circuit, which is a microchip that’s customized for a particular use.)
After taking a brief sabbatical to reflect on her next professional move, Dilligan started what would become Cooler Heads with her own money, the amount of which she declined to disclose.
She first worked with an engineering design firm in San Francisco to evaluate whether her concept of a patient-administered scalp-cooling system was feasible. She connected with the design firm based on her business school contacts from Stanford University’s Graduate School of Business.
The question she asked: Can we build a portable, patient-administered, scalp- cooling system and get the economics we need to make this a scalable business?
“I didn’t want to take other people’s money until we figured it out,” she said.
A chance to figure it out, with the support of an accelerator, came quickly thereafter.
Dilligan was accepted by Ad Astra in San Diego. She said the accelerator founders are “really committed to supporting female founders and helping them take the next steps in building their business.”
“For me, that was an incredibly positive experience, in terms of building up my network in San Diego and thinking through strategically what I needed to do, to get this company funded,” she told inter-TECH-ion.
Cooler Heads does its manufacturing in San Diego at a contract manufacturing firm.
As Dilligan lives in San Diego, her company has “a light footprint” in the Mission Valley business district.
SoCal Life Sciences Network
Dilligan said she’s grateful for the “outstanding life sciences network throughout SoCal.”
“When I talk to investors in other parts of the country, even in the San Francisco Bay Area, and tell them that I have a med-device company in SoCal, they say, ‘Yeah, that’s where the epicenter is,’” she said.
Dilligan is also thankful to have participated in another accelerator, Octane’s LaunchPad. She did this a few years ago, and got the opportunity to present at Octane’s medical technology conference in 2019. Octane is a multi-faceted organization in Aliso Viejo that presents several annual conferences. Its accelerator has been helping small businesses grow since 2010.
“Similar to Ad Astra, being part of LaunchPad (and Octane), really just opened up a whole new world of subject matter experts, especially for someone who has not come from the med-device space,” she said. “If you don’t come from the industry, there’s a lot of poking around and trial and error, so I’m lucky to be part of these consortiums that help answer these questions.”
Evolution of Cooling Device
From her own experience, Dilligan knew it was imperative that her device be portable, with wheels. A backpack was discussed early on, but rejected because some patients would be recently recovering from surgery and would not be able to carry it, she said.
The company has also done a “great deal of rigorous work,” with issues including usability testing, improving the software experience and customer training.
“We’re taking a therapy out of the clinical setting and having it be patient-administered, so there’s a lot of thought that has to go into making it usable, not intimidating,” she said.
She has branded her caps as “Amma,” which means “mother” in Tamil.
“We certainly mean no cultural appropriation, she said. “Whether you’re a man or a woman, people associate their mothers with strength and comfort. That’s what we want.”
How It Works
The way cold cap therapy works is that it enables patients to keep their hair, by keeping their scalps cold during chemotherapy. The device brings scalp temperatures to about 65 degrees – before, during and two hours after each session.
What it’s essentially doing is constricting the hair follicles, so they shut down. The goal is that they not absorb the chemo when it’s strongest in the patient’s system, she explained.
Cooling the scalp evenly, in a gentle manner, typically enables patients to keep most of their hair, she explained.
A patient would put on a cap when they first get to a chemo center, even before they’re given pre-meds, steroids and anti-nausea medications. To start the process takes the simple push of a button. When the chemo has been administered, they hit another button to begin the post-session, two-hour countdown.
How cold and comfortable is the device when you’re wearing it? It’s hard to gauge another person’s level of discomfort, Dilligan said.
“I’ve done it with dry ice packs that are placed on the patient’s head,” she said. “Those cause what’s known as brain freeze, where you get that sharp headache for a few minutes. Some will experience that with Amma.”
“Amma is more comfortable because it has a cool-down process, which habituates the patient to the cold as the temperature drops,” is her opinion.
The temperature of the device itself goes to below-freezing. That’s because the fluid has to get close to 32 degrees in order to get the scalp to 65 degrees.
“It absolutely is cold,” she said. “We tell patients to bring a blanket and a sweatshirt.”
But blood flow is always doing its part and warming up the body, she added.
Cooler Heads has raised almost $4 million from investors in total. Most recently, it closed a pre-Series A round of more than $2 million, comprised of institutional and angel investors.
Some of the investors include Anathem Ventures, Robin Hood Ventures and Crescent Ridge Partners, as well as physicians Stan Marks and Sandeep Bansal.
A Series A raise is next, Dilligan said, after Cooler Heads has gotten its device to market.
This milestone was achieved in October — and was noted as a stellar achievement, since at that time she had raised less than $2 million.
“In an era of overblown tech copycats, Cooler Heads is proof that unique, idiosyncratic technology companies that deliver tremendous value to their investors still exist,” Anathem Ventures Managing Partner Crystal McKellar said in a press release. She became a Cooler Heads board member after Anathem invested in the company.
Partnering with Clinics
Cooler Heads is starting slowly and methodically to identify select medical centers.
It’s looking at a combo of academic and community centers in SoCal and a few others scattered across the country. Focusing on a mix of urban and rural areas is important, Dilligan noted, so the company can understand the circumstances of patients in a variety of settings.
Starting out with just a few centers gives Cooler Heads plenty of time to refine the product and the training.
“We have a lot of work to do, in terms of our training process and learning how to care for our customers,” Dilligan said.
Dilligan intends for the business model to start with customers paying out-of-pocket. However, the startup
is working towards getting insurers — including Medicare ؙ— to cover the cost of it eventually. That’s a multi-year process, Dilligan explained.
The projected cost is $2,000.
Compared to how much the average American woman spends a year on health and beauty products — $3800, according to online research she’s done — it’s affordable comparatively, in her opinion.
She spent more than $8,000 to keep her own hair during chemo treatments, using dry ice systems that “are unwieldly to use and very uncomfortable,” she said.
That being said, the pilot programs — which are expected to launch this Spring — are going to be getting the Amma caps at a slightly-discounted rate. Dilligan declined to say how much that discount would be.
“As we grow we’re going to work on decreasing the cost, and part of that is also getting insurance reimbursement for it,” she said.
The main competition to Cooler Heads is existing companies that have been providing non-portable devices at chemo centers for decades. Cooler Heads’ differentiators are that its device is portable and can be totally administered by the patient, without a helper or coach.
In early March, Cooler Heads was one of eight women-led health startups selected as finalists in the Fire Pitch Competition in Houston, hosted by the Ignite Healthcare Network. That’s a nonprofit comprised of women execs committed to advancing innovative healthcare solutions.
“Industry recognition at this key time in our evolution is critical to our long-term success, and the network they bring is powerful,” Dilligan told inter-TECH-ion.