Major medical device companies and investors are interested in medical device technologies for treating heart failure due to the large potential size of the market. The market for short-term LVADs is $1B in existing device sales, growing historically 20+ percent annually in CorInnova's initial Bridge to Decision/Recovery indication. The total addressable market is estimated to be $4B per year, and CorInnova’s device could expand that market by 50% to $6B per year. CorInnova’s device would expand the market by providing a treatment option for patients ineligible for currently approved cardiac assist technology. CorInnova’s initial addressable short term assist markets include: (1) patients not eligible for existing devices; (2) patients who fail to wean from bypass; and (3) competitors’ current addressable market, plus current VA-ECMO sales; this excludes competitors’ market for use in high-risk percutaneous interventions (high risk PCI), which is used for a few hours during surgery while stents are placed in patients).
New patients who may be treated by the CorInnova device include:
Bridge to Decision/Recovery patients (where a patient is supported until a decision can be made as to whether to the patient can receive another longer term device or for recovery and discharge
Bi-ventricular heart failure patients
Anticoagulation intolerant patients (anticoagulation is necessary with blood contacting LVADs)
Chemotherapy-induced heart failure patients (these are clotting prone patients who cannot use LVADs)
Patients with a short term viral heart infection (e.g. myocarditis, peripartem cardiomyopathy) for short term support to recovery
Portion of HFpEF patients (diastyolic HF) which have no FDA approved devices
CorInnova’s device may lead to cardiac restoration in heart failure patients in much greater frequency than in LVAD treatment (now estimated at 1 to 2 1/2%) by correcting motion, reducing wall stress, and normalizing cytokine signaling – key factors in restorative cardiac remodeling.
Providing biventricular cardiac assist without touching the blood has the potential to create a new paradigm of acute heart failure treatment.