Major medical device companies and investors are interested in medical device technology for treating heart failure due to the large potential size of the market. LVADs are a life-saving technology and complex to implant; the device systems cost roughly $100,000 for each patient. A major investment bank estimated that current LVADs have a potential market of $4 B in the US alone despite the limitations of invasive implantation and blood contact. However, heart failure device sales could be many times larger with less invasive devices.
CorInnova's technology could address many of the patients currently ineligible for LVADs, up to an estimated addressable market of 280,000 patients or more. More frail patients could be treated by CorInnova technology, as the benefits of minimally invasive implantation and lack of blood contact include:
Much less invasive implantation
Shorter hospital stays (4 to 6 vs. 20 to 35 days for LVADs)
Absence of blood contact, so likelihood of no device-induced stroke, pump thromobosis, blood damage, or gastrointestinal bleeding, and likelihood of eliminating re-hospitalizations due to these types of adverse events.
The device also assists both ventricles, making it suitable also for biventricular failure patients.
New patients who may be treated by the CorInnova device include:
Bridge to Decision/Candidacy patients (where a patient is supported until a decision can be made as to whether to the patient can be a transplant candidate or whether the patient should be implanted with an LVAD; no devices are now approved for 30-day use in the US)
Bi-ventricular heart failure patients (there are no implantable devices for Bridge to Transplant or long-term use except a total artificial heart)
Anticoagulation intolerant patients (anticoagulation is necessary with LVADs)
Chemotherapy-induced heart failure patients (these are clotting prone patients who cannot use LVADs)
Patients intolerant of invasive LVAD surgery (age 72+)
Portion of HFpEF patients (up to 50% of total population; have no FDA approved devices).
CorInnova’s device may lead to cardiac restoration in end stage 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. The device may also prevent the development of heart failure after major infarcts by correcting the motion of the heart – this population alone could be 200,000 patients a year. Both cardiac restoration and prevention of the development of heart failure would be extremely large markets.
Providing cardiac assist without touching the blood has the potential to create a new paradigm of heart failure treatment. Addressable markets are estimated at up to $14 billion.
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