Channel Medsystems, a TheraNova spinout, is “white hot,” TheraNova President and CEO Dr. Daniel Burnett said. The company aims to treat heavy menstrual bleeding (HMB) using cryoablation.
But why is the proverbial iron hot now?
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- Last month, Channel MedSystems completed its feasibility study on four patients in Canada, CEO Ric Cote said. And, pending FDA approval, an app could help its pivotal trials move along smoothly.
- The company announced a Boston Scientific (BSX)-led $9.7 million Series B round in the spring of 2013, which largely overshadowed perhaps its bigger acquisition: Cote. Cote is a mover and shaker in the women’s health space.
- He was the executive VP of global sales at Conceptus (CPTS), which offered a nonsurgical permanent contraception, for eight years before leaving in 2012. Bayer (BAYN) acquired that company for more than $1 billion dollars in 2013. According to Cote’s LinkedIn profile, during his time at Conceptus, “revenues grew from $4mm to > $140mm.”
- Company may use mobile health to its advantage in clinical trials, rather than just as endpoint product.
- Medtech created by a team that realizes the patient is the consumer.
While Cote concedes “there are good options” to help patients with HMB, Channel MedSystems’ “removes the risk of anesthesia or even conscious sedation.” This means the less-than-five-minute procedure should work well in an office environment. Right now, the largest number of women who self-report as having HMB choose to do nothing, Cote said.
“When these procedures can be done in the office. . . you put a patient in the situation where she trusts her physician, she trusts that staff, (she doesn’t) have to go to another facility,” Cote said.
The hypothermic aspect of the treatment is also key, as the assumption is it would be well-tolerated in patients, the cold serving as a natural analgesic.
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Cote said the procedure would “still cause an ablation” but shouldn’t add the layer of scarring to it often seen in hyperthermic procedures. “We don’t believe we’ll have adhesion issues you get with hyperthermic,” he said.
A hypothermic treatment means, if the company is successful, the procedure would be less painful for the patient. Hysterectomy often follows hyperthermic treatment for HBM three to five years after such a procedure, Cote said. With hypothermic (as opposed to hyperthermic), the anatomy is preserved and leaves options open.
Finally, most existing procedures to treat HMB (excluding BSX’s Genesys HTA) require the cavity to conform to a device via suction or distension, while Channel MedSystems’ procedure uses gas that goes in as a liquid under very high pressure. This means “the liner conforms to uniqueness of whatever the cavity is,” Cote said. (See how it works in the video above.) The unique way it conforms would allow it (in theory) to reach deep and shallow pockets, offering consistent depths of ablation, which “makes it that much more tolerable and insures that we get that much better coverage,” he said.
Bottom line: It’s also more cost-effective. No anesthesiologist, no narcotics, potentially reduced need for surgical intervention down the road.
Speaking of cost-effective, the company hasn’t left mhealth out of its sights either. It is in talks with the FDA this month concerning an Android app (pending approval), Burnett said. The app, eMBLD–electronic Menstrual Blood Loss Diary–would “provide physicians and patients a tool to objectively measure and assess heavy menstrual bleeding. The application was developed to use readily available technology to provide an objective measurement of blood loss in the diagnosis and treatment of HMB,” Cote said.
The app, “developed by Thernanova in close cooperation with Channel Medsystems,” would work in tandem with the cryoablation procedure’s clinical trial, pending the FDA’s approval of it as a valid alternative for the current industry standards, alkaline hematin (AH) or a pictorial blood loss assessment chart (PBLAC), Cote said. He said though it’s an Android technology now, eMBLD’s soon to be a smartphone technology.
If eMBLD is approved as an alternative, it could mean quicker, cheaper clinical trials for the procedure. Cote said the company may be able to do single-arm clinical trials rather than randomized. Cote said in early Q2, the company should reach a design freeze on the device and hopefully begin clinical trials in Q3 or Q4 of this year.
If all goes according to plan and subject to a smooth (if non-linear) FDA process, Cote said the procedure could be commercially available potentially as early as 2017.
Channel MedSystems is in a “very good cash position,” he said. They’ll begin raising money to take them through clinical trials later this year, about $12 million to $15 million, he said. Current insiders are “anxious” to lead that round and a number of investors the company turned down in the last round of financing remain interested, he said.
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