Selera Medical

What do they actually do

Selera Medical is an early-stage medical-device startup developing a one-time, minimally invasive treatment intended to reduce chronic fluid overload in heart-failure patients by “offloading” the lymphatic system (the team calls the approach minimally invasive lymphatic offloading, or MILO). Today they are prototyping, running preclinical studies, and planning their first-in-human pilot and FDA submission; they do not have a commercial product or live clinical use, and their public website is a coming-soon page YC Fogarty site.

Day to day, the team iterates the device and procedure on the bench, tests in preclinical labs (they’ve partnered with Veranex for preclinical work), works with a key opinion leader interventional cardiologist on clinical protocols, and prepares regulatory filings and manufacturing transfer to a contract manufacturer Fogarty YC.

Who are their target customer(s)

• Interventional cardiologists and interventional radiologists: They need a safe, predictable procedure that fits cath-lab workflow, backed by human safety/efficacy data and a clear training pathway before adopting a new implant YC Fogarty.
• Heart-failure cardiologists and outpatient HF clinics: They manage patients whose congestion is not controlled by medicines and want durable options that reduce recurrent hospital admissions YC Fogarty.
• Hospital administrators, cath-lab managers, and procurement: They must justify device adoption on procedure time, training burden, device cost, and reimbursement—factors that are not yet defined for this product Fogarty.
• Patients with chronic fluid overload from heart failure failing medical therapy: They face recurring symptoms and hospital stays and want a one-time option that meaningfully reduces fluid burden and hospitalizations YC Fogarty.
• Clinical trial investigators / KOLs: They need solid preclinical data, an easy-to-use device, and clear protocols before committing patients and center resources to a pilot study Fogarty.

How would they acquire their first 10, 50, and 100 customers

• First 10: Activate the engaged KOL site to run a single-center first-in-human pilot using existing preclinical data to expedite IRB approval and enrollment; provide devices at no charge, cover site costs or small grants, and proctor hands-on to minimize setup burden Fogarty.
• First 50: If pilot data show safety and signal, expand to a small network of academic HF and high-volume cath-lab centers via KOL endorsements, publications, conference presentations, and targeted outreach, with site-initiation support (training, CRO logistics, trial devices) to reduce friction Fogarty YC.
• First 100: Begin a controlled commercial rollout at centers of excellence with flexible procurement, supported by an economic/reimbursement package and a certified proctor network; close hospital deals with clear pricing/service terms and capture early real-world outcomes to strengthen the payer case Fogarty.

What is the rough total addressable market

Top-down context:

About 6.7 million U.S. adults have heart failure, and device spending in HF is a multi‑billion‑dollar global category, indicating established buyer budgets and precedent for device-based therapies HFSA Grand View Research.

Bottom-up calculation:

Early, conservative U.S. patient TAM (advanced/refractory HF) is roughly 335k–469k (≈5–7% of symptomatic HF), while a broader pool with diuretic resistance or persistent fluid overload could be ~1.3–2.0 million; each avoided HF admission carries roughly $15k–$18k in direct inpatient costs, framing potential economic impact HFSA Diuretic resistance review NIS/AHA analyses.

Assumptions:

• Early clinical indication focuses on advanced/refractory patients; broader use depends on trial results and labeling.
• Hospital adoption depends on demonstrated safety/efficacy, procedure time/training fit, and reimbursement clarity.
• Device pricing not yet disclosed; dollar TAM depends on price and adoption rates.

Who are some of their notable competitors

• Abbott CardioMEMS HF System: An implantable pulmonary artery pressure sensor used to guide HF management; aimed at reducing hospitalizations by enabling pressure‑guided therapy, widely referenced by clinicians and payers Abbott.
• Nuwellis Aquadex SmartFlow: FDA‑cleared ultrafiltration system for targeted fluid removal in patients with fluid overload who have not responded to diuretics; used in hospital or monitored settings as an alternative to diuretic escalation Nuwellis.
• Corvia Medical IASD (Interatrial Shunt): Minimally invasive atrial shunt intended to reduce left atrial pressure and HF events in HFpEF/HFmrEF; investigational in the U.S., with ongoing studies and selective indications outside the U.S. Corvia.
• Sequana Medical DSR (Direct Sodium Removal): Investigational therapy under development for diuretic‑resistant HF that aims to remove sodium and address persistent congestion; currently in clinical studies (not approved in the U.S.) Sequana Medical.
• CVRx Barostim: FDA‑approved implantable neuromodulation device for heart failure symptom improvement; not a decongestion device but competes for HF implant budgets and aims to reduce morbidity and healthcare use CVRx.