KALAMAZOO — A Kalamazoo startup seeks to raise $5.1 million over two capital rounds to commercialize a treatment for diabetic foot ulcers that cost billions of dollars annually to treat in the U.S.
Adlore Inc.’s SenLore therapeutic boot combines heat and electrical stimulation to improve blood flow and heal wounds from foot ulcers.
Sensors embedded in the boot’s insole monitor a patient’s blood flow in the foot. A Wi-Fi connection can remotely monitor progress, while the device alerts a doctor if a patient experiences reduced blood flow that hinders healing.
Presently backed by $500,000 raised from convertible notes issued in 2020 that paid to develop a prototype and conduct a pilot study, Adlore now wants to raise another $2.5 million in a Series A capital round to complete development on a final product design.
A follow-up $2.6 million Series B capital round would pay for a clinical study needed to generate data when seeking regulatory approval from the U.S. Food and Drug Administration. That could lead to selling the intellectual property and an exit for investors by the end 2023, although Adlore could take SenLore to market on its own if it’s unable to find a suitable buyer, said President and CEO Eli Thomssen said.
The company has “been getting a lot of irons in the fire” and attracting interest from prospective investors, Thomssen said.
“This is an unmet medical need,” he said. “People recognize this is a problem and it’s in need of a better solution than what we have had.”
In developing SenLore, Adlore looks to tap a massive $327 billion annual market in the U.S. for treating diabetics, $11 billion of which goes to treat foot ulcers that can lead to an amputation. More than 8 percent of the U.S. population, or 26.8 million people, are diabetic and a quarter of the diabetic population will develop a foot ulcer at some point in their life. One in five diabetics will get will get a moderate to severe infection and undergo amputation, according to data in an Adlore investor presentation.
SenLore can enable foot ulcer patients to receive treatment and allow physicians to remotely monitor their progress at home or a care center and intervene quickly if their condition deteriorates.
“The idea is that we can monitor these wounds every day so we don’t have to wait,” said Daryl Lawson, Adlore’s chief scientific officer. “A physician or a wound clinic can see the blood perfusion in the foot every day and then be notified if it goes significantly down and call in someone right away.”
The remote monitoring also can help compliance in a patient’s use of the device, said Lawson, an associate professor at Western Michigan University’s Department of Physical Therapy who has expertise with wound management, electrophysiology and orthopedics.
SenLore’s cost-saving potential within the Medicare market for senior citizens who develop a foot ulcer is “huge,” Lawson said. Treating a diabetic foot ulcer costs an average of $12,858, according to the National Center for Biotechnology Information, a part of the National Institutes for Health.
Four in 10 foot ulcers recur within a year. Nearly two-thirds recur within five years, according to a 2017 study published in the New England Journal of Medicine that Adlore cites in its investor presentation.
Matching telehealth growth
Adlore prepares to commercialize SenLore amid a greater use of telemedicine that has grown exponentially during the COVID-19 pandemic and can lead to the potential market acceptance, Lawson said.
“It’s greeted now much more with open arms,” he said. “Physicians are getting paid for it and on the other end the patients trust it much more now, where five years ago I don’t think that was the case. It wasn’t as accepted.”
Estimating a $3.2 billion U.S. market potential for SenLore, Adlore projects sales of up to $9.2 million in the first year on the market in 2024. Sales could quickly grow to a projected $150.8 million by 2028. The company would target sales to podiatrists, wound care clinics, endocrinologists, vascular surgeons, and family practitioners.
“I think with the cost savings, the telemedicine and the efficacy of how this will work with healing a wound, it has great, great potential,” Lawson said.