265 PPP loans for digital health. Orexo Modia?

Issue 060.

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Digital health research from Brian Dolan.

Welcome to E&O.

Last week I wrote about Ostuka’s initial $15 million bit for Proteus Digital Health’s assets. Next week I’ve got something cooking, but open to more ideas — send them my way. Here’s what’s happening this week:

I spent a few days digging into the federal government’s just-released database of companies that applied for PPP loans earlier this year. I found more than 260 digital health companies listed (I’m sure there are more), including a few digital therapeutics companies. More on that below, but you can check out the E&O database of digital health PPP loan applicants right here.
In a letter to CMS this week, the AMA asked that CMS cover self-measured blood pressure monitoring as part of its extended coverage of remote patient monitoring CPT codes during the pandemic: “The AMA believes coverage of home blood pressure monitors will facilitate more coordinated patient care.”
Two weeks back, Blue Note Therapeutics quietly launched its first digital therapeutic, COVID Cancer Care. The company describes it as a “preview” of the full prescription-only, FDA-approved DTx it is building. The actual DTx will use CBT and relaxation therapy to help cancer patients with depression and anxiety.
Pear Therapeutics inked a deal with Perceptive Advisors for an up to $50 million credit facility.
True Wearables, a startup founded by an alum of both Apple and Masimo, just secured FDA 510(K) clearance for its pulse ox-sensing peel-and-stick device, Oxxium. Prior to FDA clearance, True has sold Oxxium for $40 as a device for athletes that could be worn on the fingertip, forehead, or ear.
In Issue 051 in May, I mentioned that Novartis and Propeller Health were close to a commercial launch of the Enerzair Breezhaler in the EU. This week the European Commission gave them their final blessing. Propeller tells me: “This morning we announced that we will co-package the Propeller sensor with a new asthma medication from Novartis, which was approved by the European Commission this week for use in the EU. This is the first time a digital health platform for asthma has been co-packaged and co-prescribed with a medication. It’s also the first time Propeller has gone to market with a new medication — a pretty significant milestone for us.”
In other Propeller news, longtime COO-turned-CCO Chris Hogg has left the company. More on what he’s up to next as soon as he gives me the signal…
Two new digital therapeutics startups to keep an eye on: SharpTx and Introspect Digital Therapeutics, which is an ATAI Life Sciences spinout. SharpTx, which is still in stealth mode, is based in London and will build “engaging Digital Therapeutics that help with prevention, detection, monitoring and treatment of CNS Conditions.” The better known Instrospect is a self-described “initiative” instead of a startup and is combining psychedelics and DTx.
AliveCor added a new service: KardiaCare. For $9.99 a month or $99 a year, subscribers receive one cardiologist review of their ECG every 90 days, among other features.
Finally: The Digital Therapeutics Alliance is looking for a CFO/COO on a temp-to-perm basis. In recent months, the DTA has become more of an official lobbying force on the Hill. I’m curious to see what kind of progress they can make with CMS coverage.

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Database: More than 260 digital health companies applied for PPP loans

This week I put together a searchable, sortable database of more than 200 digital health companies that received PPP loan approvals from the federal government this year. So far. The program just re-opened for round two applications, so this list will likely grow.

As one reader noted, these are the companies that applied and received approval for a loan. They may not have actually taken the money.

So far, Lark and BrightMD have told me that they did not end up taking the loan, while Wildflower Health confirmed that they did. Zocdoc told another publication that they did execute the loan, but then they returned the money. Zocdoc, however, have yet to get back to me to confirm that.

If the list grows a bit more, I’ll add a new column to indicate the status of the loan. If your company is on here and you can send me that update, please do: b@exitsandoutcomes.com.

Orexo to launch three DTx in 2020: deprexis, vorvida, and… Modia?

Thanks to the FDA’s non-enforcement guidance on digital health devices for psychiatric disorders, Swedish pharmaceutical company Orexo has decided to launch its first two digital therapeutics — focused on depression and alcohol use disorder — into the US market this month:

“Orexo announces today the US launch of the scientifically proven digital therapies deprexis and vorvida, for treatment of symptoms of depression and management of problematic alcohol misuse respectively. deprexis is available to patients from July 1st and vorvida from July 15th. The decision to accelerate the launch is based on the patient need for access to low-risk clinically-validated digital health devices during the ongoing COVID-19 pandemic and the recent US Food and Drug Administration (FDA) ‘Enforcement Policy’ providing a fast pathway to market for digital therapies for treatment of psychiatric disorders.”

Orexo also shared that “OXD01, a digital therapy for the treatment of opioid use disorders, will be accelerated and tested in collaboration with selected customers in Q4 2020, in preparation of a broad launch in Q2, 2021, a year ahead of original plan.”

I believe Orexo will eventually brand OXD01, its opioid use disorder DTx, “Modia”, because the company filed a trademark for that name for an unspecified digital therapeutic product a few weeks back.

In its announcement this week, Orexo shared that it has spent about $12 million in one-time payments for licensing and developing the digital therapeutics products with its partner GAIA. Orexo also upped its expected operation expenditures for 2020 by $21 million because of the accelerated rollout of the three digital therapeutic products.

Here’s what the company said about go-to-market plans and expectations:

“Initial revenues from digital therapeutics are expected in Q3 2020 and total net revenues in 2020 from digital therapies are dependent on the pace Orexo can secure product reimbursement. The launch of Orexo’s digital therapies will initially focus on securing access and reimbursement with a selected group of payers, leveraging Orexo’s long relationship with many payers in the US. As access and reimbursement is established, Orexo will increase the sales force and direct marketing efforts to promote the products directly to relevant healthcare professionals.”

Proteus cancer pain study pushes to 2021, while an OUD DTx study tests out virtual pet incentives

Proteus Digital Health study with cancer patients set to continue: This week a study focused cancer patients with uncontrolled pain that is set to use technology provided by Proteus Digital Health got an update. It will now be completed in late 2021 instead of this coming October. Southwest Oncology Group is sponsoring the study, which will enroll 60 people:

“This is a feasibility study to assess the use of a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain.”

Virtual pet vs monetary incentives vs DTx: This feasibility study from a researcher at Rutgers University “will develop a mobile health app to improve the appropriate use of opioid medications among patients with a prescription to treat non-cancer pain.”

What’s unusual about the study are the active comparators the researcher plans to use.

The control group will just use the smartphone app.
One active comparator: “Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which can be used in the care of a virtual pet.”
The third group is also an active comparator: “Subjects will use the smartphone app to manage use of prescribed opioid medications to earn points, which will be paid out at the end of the one-week trial in the form of a monetary reward.”

Owlet Band for expecting mothers: Owlet, which is best known for its newborn wearables and tracking apps, announced a wearable for expecting mothers at CES 2019. Now it’s beginning an observational study of users of the device, which it stresses is not a medical device (yet?). It hopes to include 8,000 expecting mothers:

“The purpose of this research is to observe if using the new Owlet Band and the associated iPhone app can help pregnant women in managing their habits, anxiety, stress, enhancing bonding and attachment to their infant, while still maintaining their standard medical care.”

Quick links: E&O research reports and databases

The links below aim to make it easier for paying subscribers to find the long-form research reports and databases on the E&O site:

Database: Digital Health PPP Loans (Open access)
The Proteus Digital Health Report (Subscribers-only Link)
The Hinge Health Report (Subscribers-only Link)
The Digital Health Enrollment Report (Subscribers-only Link)
The Omada Health Report (Subscribers-only Link)
The Google Health Report (Subscribers-only Link)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)

That’s a wrap on Issue 060 of E&O.