From accessing prototyping labs to investors, business plan competitions and much more, LAS moves with momentum towards incorporating their device in the intra-operative setting.
It all started at the Beckman Laser Institute with a trio of colleagues who, between all three skill sets, discovered an urgent need for efficient and accurate hemodynamic monitoring in the medical industry.
Enter the inception of Laser Associated Sciences.
LAS’ three co-founders, Sean White, Ph.D., biomedical engineering, LAS chief executive officer, Bruce Yang, Ph.D. biomedical engineering, LAS chief engineer and Tyler Rice, Ph.D., physics, LAS chief technology officer, focused on different aspects of biophotonic technology to create the ideal user-friendly hemodynamic monitoring system. Coupled with BLI’s abundant onsite resources and “bench-to-bedside” capabilities, the team had the opportunity to interact with clinicians who focused on different areas of medicine, which was not limited to dermatology, vascular surgeries and interventional radiology at BLI.
“When you’re an academic, you work on this bleeding edge of the latest and greatest technology,” said White. “As we were bringing these technologies into the clinic, we realized if we were ever going to make something that really saw clinical adoption in a commercial/impactful way, it needs to be simple.”
Peripheral Artery Disease
Primarily focused on peripheral artery disease (PAD), which is a common circulatory condition in which clogged blood vessels reduce blood flow to the limbs, the system essentially detects blood flow utilizing, as the team refers to, a camera the size of a postage stamp and a small laser diode. The device clips onto a toe to measure blood flow in the arteries, veins, and capillaries.
“This is important because some of disease progression might not be arterial related,” said White. “But it may be related to the microvascular level flow, as well—that is important.”
PAD is one of the leading causes of lower limb amputation, according to White, which attributes to approximately 150,000 lower limb amputations in the United States each year. Among the estimated 8-to-12 million Americans who have PAD, most are asymptomatic.
“If you are able to diagnose earlier, [there are medications] that you can take to help improve long-term outcomes, which was the goal when we started this —‘can we develop a technology to diagnose this earlier?’” said White.
PAD is commonly detected via ankle brachial index, or a test that measures the ratio of blood pressure in both the legs and arms. Theoretically, both measurements should read the same, however, if a patient has disease in their leg, the blood pressure will read less than the blood pressure in their healthier arm.
“There are an enormous number of issues with this test, not least of which is time consumption,” said White.
Additionally, primary care physicians often do not implement ABI and patients are often referred to a vascular clinic, according to White. The ABI’s sensitivity and specificity rates are not very high quality, as well, and compressibility proves to be an issue to determine accurate data.
“Diabetics tend to get calcified arteries, and it’s literally what it sounds like—the arteries themselves literally are harder,” said White. “If you are squeezing the artery and letting it go, you can’t do that accurately in a diabetic person—it causes the blood pressure readings to be erroneously high.”
Meeting their KOL
In 2015, LAS had the opportunity to meet Mahmood Razavi, M.D., vascular and interventional radiologist at St. Joseph Hospital in Orange, California. The team admired him for his work in and out of the clinic. In addition to his clinical practice, Dr. Razavi has also had multiple ventures in the medical device/startup space and currently serves on several advisory boards.
“He is the kind of person you get five minutes with at a time and he will usually say ‘no thanks’ and just walk away,” laughed White.
But not this time. After cold-calling their revered key opinion leader, the team was invited to stop by St. Joseph Hospital where Dr. Razavi provided feedback about their early device.
“It was very clear to me that this technology occupies a really nice unmet need, which is intra-procedural blood flow monitoring,” said Dr. Razavi. “There is no good way to monitor blood flow intra-procedurally in real time. We don’t always understand the impact of angiographic changes on the patient’s outcome, so this is a great way to monitor flow during and after the procedure.”
Dr. Razavi noticed the instantaneous changes in blood flow measurements during his procedures while treating the blocked arteries and remarked that the technology looked very promising. During his procedures at the time, Dr. Razavi identified arterial blockage by performing an angiography, or using continuous x-rays to visualize the blood vessels after injecting a radiopaque substance.
“I find the device very useful,” said Dr. Razavi. “It provides critical information during the re-vascularization procedures—it tells us when we have done enough and when we haven’t. Currently, we have nothing else that gives us that kind of information in real time except an angiogram, which has its own [physiological] limitations.”
Dr. Razavi recommended the team to pursue an out-patient home monitoring product as well and to bring the cost down. Because the device is electronic, the patient’s data could then be transferred to a clinician’s device where they would be able to monitor their patients outside of the clinic.
“These are three very smart engineers who are completely aware of the trends in medicine in general and PAD in particular. Trends like the aging population and increased prevalence of diabetes and metabolic syndrome” said Dr. Razavi. “They were able to implement the outpatient monitoring idea, which showed me they can modify the technology very quickly to meet our needs.”
Their shoe box-sized hemodynamic monitoring system eventually whittled down to a user-friendly smaller size to accommodate clinicians and patients. With the greatest temptation of versioning their model names after Star Wars ships, specifically the Boba Fett ship, four generations and more than 27 different internal versions later, the team stuck with simpler versioning structure (sans Star Wars) to develop their latest and greatest.
The technology’s size and appearance was dependent on the camera, which at the time of their first generation, was the size of a baseball, and a standard laser pointer-sized laser diode.
“I feel like a lot of what enabled us to really improve the technology right now as opposed to 10 or 20 years ago is the development and improvement in CMOS cameras,” said Rice. “So, all of your phone’s cameras–there has been a ton of effort in the consumer market to make these cameras smaller, higher resolution and lower power.”
The goal is to use this technology in the intra-operative setting so as a clinician is operating on patients, they can detect blood flow in real time.
“No one’s done this before,” said Rice. “We’re really excited when we feel like the device can be useful. Maybe our device contributes to saving a person’s toe or limb. That’s a great feeling and [the reason] why we got into this–to help people.”
From Pool Table to the Cove @ UCI
From Yang’s garage and pool table to now a resident at the Cove @UCI, LAS utilizes all aspects of the Cove prototyping lab to create models. Originally working out of BLI, the team began as a consultant for the prototyping lab at the Cove and eventually moved into an incubation space once the Cove was complete.
“We love having access to this lab that has all this equipment, which makes no sense for us to buy,” said White. “Another part of it are the optics. We [recently] had two doctors come in for dinner. It’s nice to have access to a really attractive space and conference rooms. It may sound a little silly, but you need that.”
At first, most of LAS’ funds came from their own pockets, but it was soon realized that more funds would be needed to move the device to the next level. In 2013, the team won first place in UCI’s Business Plan Competition from the Paul Merage School of Business.
“It was a real labor of love, so when we won that competition, there was actually a $15,000 cash prize,” said White. “And at the time, coming out of grad school, it felt like a million bucks.”
Despite their entire winnings paying entirely for a patent attorney, the team kept moving and won an additional $15,000 from Chapman University’s international business plan competition California Dreamin’. Following this competition, they took home $50,000 in UC’s system-wide business plan competition, Prime UC.
“It was obviously validating, it was telling us we can do this,” said White. “Our idea has some substance behind it.”
After receiving those funds, LAS was able to develop the technology further and began clinical investigations. The team soon began to realize the need for an investor. Their ideal candidate would be able to provide critical feedback where needed, but also trust the team’s skill base. After watching LAS present at a 1 Million Cups event at the Cove, a graduate student introduced them to Shiv Grewal, co –founder of Auctus Global Capital Group.
“It’s always good to have aligned professional vision, which we did but we also gained a lot from personal perspective, which was really important for us,” said White.
As the first investors, Auctus Global Capital Group also introduced LAS to several others for their first round of investments, which they closed in March 2017.
LAS set milestones and submitted a number of new US and international patent applications. Around December, namely the holiday season of 2017, the team received their primary method and device patent.
“It was a great Christmas present for us,” said White.
Most recently, LAS completed a 100-patient clinical study, which compares their device to the gold standard of vascular care.
“There is nothing out there that is really the tool that a clinician reaches for when they want to assess vascular health,” said White. “You have all these different technologies, but nothing has become the winner.”
LAS’ device measures blood flow in the skin, arties, veins, capillaries—the whole circulatory shebang, all while maintaining simplicity and user-friendliness. The team is driven by the need to fill the gap of the all-encompassing hemodynamic monitoring tool.
“We really want it to be us,” said White. “We think the reason why we can do it is because we are measuring something that no other technology is measuring right now and it’s really simple to use.”
In addition to planning their next round of funding, LAS are also preparing a larger clinical validation study with the goal of determining normal and abnormal blood flow for the everyday user. Echoing the advice from Dr. Razavi, their primary goal is intra-procedural modeling while also simplifying the device for at-home use.
“I think by having people put on the device and understand whether their blood flow is normal or abnormal is going to be really important for the intuition and adoption of the technology,” said White.
All wookies, Boba Fetts and Star Destroyers aside, their next gen device has the potential to make waves in the ever-expanding healthcare and medical device space.