Sublingual and inhalable cannabis products
Keluche's company licenses products made using a patented process called bubble drying. It was initially developed in order to create a measles vaccine which wouldn't require an injection with a syringe -- the vaccine could be inhaled directly into the lungs. Furthermore, the powdered vaccine would have a longer shelf life than traditional vaccines.
Keluche says, "The technology is really centered around taking any active pharmaceutical ingredient -- usually sensitive ones -- and then stabilizing them, and making them more bioavailable."
According to the company's website, the process was principally developed by biochemist Dr. Robert Sievers, a professor at CU-Boulder. His company AKTIV-DRY received $20 million in funding from the National Institutes of Health (NIH), which was supplied to the NIH by the Bill and Melinda Gates Foundation. The goal of Sievers' company was to develop a measles vaccine for India.
In 2014, Sievers and his partners formed Sievers Biotech, after becoming interested in using that same technology to prepare dry-powder formulations of CBD, a cannabinoid lauded for its anti-seizure, anti-pain, and anti-anxiety properties.
With Sievers serving as senior scientific advisor and his daughter, Christie Sievers Spencer, taking on a management role as vice president, they've formed KelSie Biotech with Keluche and others. ("KelSie" being the first three letters of the names Keluche and Sievers combined.) It's KelSie's job to license products using that bubble-drying technology.
Some of KelSie's principal players also have mutual ownership in a Marijuana Infused Products (MIPs) lab in Boulder. That's where a licensed product line called SUM Microdose is being made. The SUM products are intended for sublingual use (the tablet's active ingredients enter the body after being placed under the tongue). In the future, Keluche predicts that the company's inhalable powdered technology -- which isn't smoked or vaped, it's simply drawn deeply into the lungs -- will also be introduced onto the medical and recreational cannabis market.
The first products from SUM Microdose were released last July, containing different ratios of CBD to THC. For instance, the product "Calm" has 3.6 milligrams of CBD and 1.4 milligrams of THC per dose; "Focus" has a 1:1 THC to CBD ratio of 2.5 milligrams; and "Energy" solely contains 2.5 milligrams of THC. A product called "Sleep" will soon be introduced, containing a third cannabinoid, CBN, which is believed to promote sleep. In addition to the sublinguals, there's also a roll-on topical which can be used to address joint aches due to arthritis or skin problems; it contains an overall content of 150 milligrams of CBD and five milligrams of THC.
The SUM brand can be presently found in around 60 cannabis dispensaries in Colorado -- and Keluche says other states will soon follow. "Month to month, we're probably [experiencing about] 15 to 20 percent on average growth," he says.
The SUM Microdose web site says about its sublinguals, "We have patented the ability to convert any cannabinoid into micro-powder optimized for bioavailability and maximum efficiency. Then the micro-powder is pressed into quick-dissolving tablets." Keluche describes the bubble drying process as being able to convert isolates like CBD "from crystalline into [an amorphous state], and we stabilize them in that state."
He says the bubble drying really does turn the cannabinoids -- mixed together with pharmaceutical-grade stabilizers and bioavailability enhancers -- "into bubbles or hollow spheres." Furthermore, the micron sizes of the particles can be formulated so that smaller particles easily penetrate from the lungs into the bloodstream via inhalation, or larger-sized particles stay within the skin without entering the bloodstream, as in the case of a topical.
Before co-founding KelSie Biotech, Keluche, 32, studied cognitive neuroscience at the University of Denver. "It, at least, gave me a scientific basis, so I could talk the scientists and translate it to the business worlds," he says.
Keluche sees other eventual uses for the company's bubble-drying technology -- including, as originally intended, for vaccines. But, for now, Keluche says that KelSie Biotech isn't operating in "the cannabis space any differently than we would in the traditional pharmaceutical space."
Challenges: There are legal limitations regarding how companies can market cannabis products. Keluche says, "Right now [the challenge is] being a medical company, a biotech company, that actually does have the scientific backing -- but then not being able to actually make the claims or the statements to support it."
Opportunities: Being able to develop products right now for the medical and recreational cannabis markets, prior to the advent of the pharma industry entering the field. Keluche says, "We're waiting in the space to see where and when pharma's going to start participating." Keluche explains the uniqueness of his company's position: "We are in this somewhat gray area where we are able to bring products to market [in medical and recreational cannabis stores] without going through full [clinical trials]."
Needs: KelSie needs to make sure that budtenders -- who ultimately explain and sell the company's products to consumers at dispensaries -- understand the nature of the sublingual products. "We really have to educate them on what it is," says Keluche. In other words, the sublingual need to be placed under the tongue, not swallowed, or it in essence becomes a less effective edible instead.