ProSomnus, Inc.·Healthcare

I initiate coverage on Inspire Medical Systems (INSP) with a speculative buy, citing its innovation and leadership in hypoglossal nerve stimulation for obstructive sleep apnea. INSP's depressed 1.6x EV/Sales valuation, versus its historical 8–12x range, presents a compelling long-term entry point despite current reimbursement and competitive headwinds. I expect the Inspire V rollout and expanding ambulatory surgery center penetration to drive growth, with CMS reimbursement issues likely to de-risk progressively through 2026.

– The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction in adults with hypertension – – Topline results from the Phase 2 Explore-OSA exploratory trial did not reduce AHI; demonstrated a clinically meaningful reduction in blood pressure and favorable safety and tolerability in this population with difficult to control hypertension – RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs.
ProSomnus, Inc. manufactures precision oral appliance therapy devices for the treatment of obstructive sleep apnea (OSA). The company was founded in 2016 and is based in Pleasanton, California.
Healthcare
Medical - Devices
136
2021-07-28
0.21