This article was originally published in Start Up
A would-be pulmonary pioneer enters the market via intubation.
You may also be interested in...
Pulmonologists, a group of device-friendly physicians without many tools at their disposal, treat large diseases with unmet needs like emphysema, asthma, and lung cancer. They thus represent an attractive, untapped market for medical device companies. Many companies targeting emphysema have been formed by executives from the interventional cardiology industry and aim to follow the tried and true path of that industry, of introducing new minimally-invasive versions of open surgical predicate procedures. Others are following the tougher route of working in diseases like asthma, for which no device predicates exist. Companies hope to offer high volume procedures that will grow interventional pulmonology from a niche specialty treating end-stage cancer patients to a specialty that routinely performs millions of procedures on patients with non-malignant diseases that are currently poorly managed by drugs.
It's more than a coincidence that cardiology company Boston Scientific has invested in Broncus Technologies and its rival Guidant, in Spiration Inc., two start-ups with minimally-invasive devices for the treatment of lung diseases. Interventional pulmonology could just be the next double-digit growth area to succeed interventional cardiology, which is maturing; what's more, it takes advantage of the core competencies of the big firms.
US FDA’ s latest ‘n of 1’ guidance describes clinical considerations for INDs to support dosing and monitoring of an individual with a life-threatening genetic disease who is eligible to receive an ASO; recommendations apply only when a few patients may be candidates for treatment.