From new medical therapies designed to limit opioid use and abuse to innovative technologies that deliver valuable data, companies throughout Florida are confronting the opioid crisis head-on.
State public officials share the same sense of urgency: Florida became one of six states that declared opioid addiction a public health emergency in 2017 as opioid-related deaths in the state rose 25 percent last year over 2016. In March, the state Legislature passed a bill that restricts certain opioid prescriptions to three days and authorizes $53.5 million for treatment and prevention efforts.
But perhaps the most intriguing developments are happening under the radar at Florida startups and healthcare companies where new, sometimes far-out, services and treatment are being produced. U.S. Stem Cell Inc. in Miami, for instance, is pioneering the use of stem cells found in fat to replace damaged tissue, often the source of chronic pain.
Tampa-based Lumina Analytics is working on real-time data analytics that could help prevent overdoses, while Gainsville-based etectRx has developed a smart pill embedded with a wireless sensor that could track whether patients take medications as prescribed.
More than a pill
The smart capsule developed by etectRx is called an ID-Cap and enables tracking the ingestion of medications, which can help healthcare providers identify and monitor whether drugs are being abused or taken as prescribed.
“There’s a general recognition that the problem in the U.S. is that people don’t take medications as they should” for many medical conditions, said etectRx President and CEO Harry Travis. “If there were better adherence then your cholesterol would go down, for example.”
EtectRx’s ID-Cap uses digital technology to monitor drug delivery and adherence, with the goal of helping doctors track their patients’ compliance and tailor drug treatments based on real-world data. The capsule contains an ingestible, embedded wireless sensor that emits a radio signal that is then captured by a wearable reader. The reader connects to an app that sends time-stamped data to a cloud-based platform monitored by the patient’s care team.
The ID-Cap’s impact on opioid adherence recently was tested in a small study at Boston’s Brigham and Women’s Hospital, where researchers found that the technology could be used to identify when a patient is changing from normal, therapeutic use to behavior that’s potentially dangerous and may lead to opioid abuse.
That same technology could also provide support for effective opioid treatment, Travis notes. “It is getting harder and harder for physicians to write large orders, but there will always be a large number of patients in chronic pain for whom opioids are an appropriate therapy, and this can give a view into that ingestion pattern,” Travis said.
The company, which recently moved into the Innovation Hub at the University of Florida, is privately held and currently in its first institutional investment round of financing, which is expected to close by summer. EtectRx is already in discussion with academic institutions and medical centers looking to explore ways the technology could be used to manage patients on opioids.
A nonaddictive alternative
Miami-based Ketamine Health Centers was founded by two brothers, Raul and Francisco Cruz, board-certified doctors of anesthesiology and psychiatry, respectively. The center offers ketamine infusion therapy for patients suffering from treatment-resistant depression and chronic pain.
“The two go hand in hand,” said lead anesthesiologist Raul Cruz. “Anyone who has chronic pain has depression” of some type. “It’s going to happen because it’s a vicious cycle.” Not only does chronic pain take its toll, eventually, but trying to withdraw from opioids can make people depressed. “Many of our patients come in with a history of opioid dependence. Almost everyone I see is addicted," he said. "Even if there is a medical purpose, a lot of the opioids are not doing the job anymore.”
Ketamine, on the other hand, treats that same pain with no real physical dependency, he explains, and thus the patient relies less and less on opioids. “It works on a cascade of different transmitters, including opioid receptors, but also serotonin, norepinephrine, and glutamate, which is the most important.”
Once known as the street drug Special K, ketamine, when administered in low doses intravenously, has a high success rate in managing pain — with almost immediate relief. The treatment can be tapered specifically to help opioid-addicted patients begin reducing their intake while lessening the discomfort of withdrawal. In addition, it’s effective for pain syndromes such as fibromyalgia.
“We always knew that pain and depression were connected, and we wanted to focus on both from the beginning,” said Cruz. With two new centers opening in West Palm Beach and The Villages in Central Florida this spring, Ketamine Health Centers is expanding its geographic footprint by 200 percent since launching just a year and a half ago.
Treating the source
U.S. Stem Cell Inc. has pioneered regenerative treatments designed to alleviate the sources of chronic pain, thus reducing or eliminating the need for opioid regimens in the first place. The company’s proprietary Adipocell stem cell kit enables physicians to harvest an individual’s own stem cells, found in a high percentage in fat tissue, and reinsert them into the targeted area in a minimally invasive procedure without general anesthesia.
The purpose of these naturally occurring stem cells is to replace damaged tissue, says Dr. Kristin Comella, U.S. Stem Cell’s chief science officer. “By redirecting them to affected areas, we’re addressing the root cause of the pain” rather than using opioids to mask the symptom, she said.
Since 2001, this technology has been used more than 10,000 times worldwide, most often for common pain points. including orthopedic treatments for knees, shoulders and backs. The treatments are offered by a network of more than 280 independent physicians and clinics across the country.
This year, the company says it has seen an “explosive demand for stem cell treatments,” generating a 92 percent increase in revenue for the first nine months of 2017 compared with the same period in 2016, and a 158 percent increase in gross profits, for a total of $2.8 million for the same period.
Comella says demand has increased as more Americans become educated on alternatives to traditional opioid medications to treat chronic pain. She foresees a future where stem cell infusions are administered prophylactically, “almost like a checkup or teeth cleaning.”
“In the near future, people are not going to wait until the pain is at a certain level [to get help], and they’ll address issues as they come up.”
Filling the knowledge gaps
The newly formed Mission LISA Foundation is a not-for-profit data aggregation project focused on addressing the opioid crisis and created in partnership with Lumina Analytics, a Tampa-based firm that provides predictive risk sensing solutions for corporate and government clients. The three-year-old firm specializes in real-time data analytics and reporting services that, through the foundation, will give policymakers and healthcare service providers much-needed insight, says Katie Sogolow, VP of Mission LISA and a senior director at Lumina.
“We had conversations with stakeholders and our clients in healthcare, and there was a common theme — there was a need for more timely and relevant data,” Sogolow said. The most recent data has a one- or two-year lag time, she explains, and the data sets themselves often don’t converge. There are 14 different reporting standards for overdoses in the state of New Jersey alone, Sogolow notes, from the coroner’s office to emergency responders.
Mission LISA’s expert advisory board — which includes researchers, academics and policymakers — will identify knowledge gaps that need to be filled to drive data-mining efforts. Findings will then be communicated and rolled out in an open-source format so stakeholders can immediately put them to use. Eventually, the foundation plans to oversee a charitable arm responsible for allocating funds to targeted, outside efforts and programs.
In the coming weeks, Mission LISA will publish its first policy recommendation, focused on overdose prevention. Analysis of the data shows that more than 90 percent of opioid overdoses are not fatal, Sogolow explains, yet there’s a very high likelihood of a second overdose within just 24 hours when there are still residual drugs in the system. “So we’re looking to identify the high-risk groups and the best ways to intervene — to determine what are the best ways to address that very vulnerable patient.”