Participated · Seed · Jan 2023

CARI Health is building what it describes as the world’s first wearable medication monitor to enable remote medication monitoring and improve treatment compliance. The company plans to use the newly awarded NIDA SBIR Fast Track grant to support product development and conduct human clinical studies. It is eligible to receive up to $2.8 million over three years as project milestones are completed across Phase I and Phase II. CARI Health has previously received investments and support from the San Diego Angel Conference, NuFund Venture Group, Cove Fund, Chemical Angel Fund, Device of Tomorrow Capital, and several individual angel investors. The company also secured investments and accelerator support from the Cedars Sinai Accelerator and the Rady Venture Fund (UCSD), and participated in programs including the Institute for the Global Entrepreneur MedTech Accelerator at UCSD, MedTech Innovator, and EvoNexus. Founder and CEO Patrik Schmidle launched CARI Health following a family member’s struggle with opioid use disorder, and the firm says the grant will enable it to move toward human trials and broader deployment. CARI Health is building a wearable remote medication monitoring device that provides clinicians with real-time medication levels to enable tailored dosing and verify adherence. The company’s first clinical application targets patients on medications for opioid use disorder to allow remote proof of treatment compliance. CARI’s device is entering first in-patient human clinical studies and the company is preparing for the FDA regulatory pathway. Earlier development was supported by non-dilutive SBIR grant funding and participation in accelerator programs including Qualcomm Institute Innovation Space, UC San Diego’s MedTech Accelerator, and MedTech Innovator. The company says it will expand its intellectual property portfolio as it readies the product for regulatory clearance and commercial launch. CARI Health is based in San Diego and anticipates a subsequent financing round in the second half of 2023 to support regulatory and commercialization efforts.

Participated · Series A · Sep 2019

Zylö Therapeutics has developed the Z-pod® technology, a topical delivery platform intended to extend duration of effect, improve targeting, and enhance performance of therapeutic and cosmetic agents. The Z-pod® platform can be adapted to provide sustained topical delivery of nitric oxide for multiple therapeutic indications. The company reports progress on product candidates including an erectile dysfunction program and a cutaneous lupus program, and seeks partners to conduct human studies for applications such as aging, hyperpigmentation, acne, and diabetic foot ulcers. Proceeds from the Series B financing will be used to complete high value-add internal research projects, scale up manufacturing of Z-pod® particles, and fully implement ISO-9001 and cGMP quality systems. Zylö says the funds will extend its runway and hedge against recession risk over the next two years. The company is based in Greenville, SC. Zylö Therapeutics has developed the Z-pod™ topical delivery platform and a proprietary nitric-oxide-releasing topical drug candidate aimed at treating erectile dysfunction. The company was awarded a $1.7M Phase II SBIR grant from the NIH (NIDDK) to advance the program into human trials. Planned uses of the funds include scale-up of manufacturing, implementation of a cGMP quality system, required toxicity testing for an IND, and a pre-IND meeting with the FDA. In a Phase I award (~$225,000), Zylö reported compelling results in a radical prostatectomy rat model: a single topical application produced an average of 2.0 erections in 60 minutes, and pre-dosing with a 1/10th human-equivalent dose of sildenafil increased erections to 4.6 and halved time-to-initial-erection. If approved, the candidate would target men with ED after radical prostatectomy and men with age-related ED who do not respond to or cannot take PDE5 inhibitors; Zylö cites a U.S. addressable market of over $2 billion per year. The company also highlights potential broader applications of the Z-pod™ technology such as wound healing, atopic dermatitis, gingivitis, and sports recovery.