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

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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.