What will the HeartSentry life cycle look like?
The HeartSentry is expected to be a reusable product but may also be marketed as a fee per use business model.
Is the technology scalable – i.e. for consumer use?
The technology is designed to be developed into a professional product and potentially as a consumer product pending FDA market approval.
How does the 510(k)-clearance process compare with having to do clinical trials?
The HeartSentry requires FDA “clearance” (i.e., 510(k) clearance) before the device can be marketed and sold within the United States. The clearance requires a manufacturer to demonstrate to the FDA that their product is “substantially equivalent” to a product that has been previously cleared by the FDA. The 510(k) process for the HeartSentry requires data obtained from clinical trials to support substantial equivalence.
I have heard that HeartSentry is entered into the Expedited Access Pathway or the FDA Fast Track programs. Is that correct?
That is incorrect – the FDA EAP (Expedited Access Pathway) is typically used for products that require an IDE (Investigational Device Exemption) approval from the FDA for conducting a clinical study prior to premarket approval. The HeartSentry does not need to use this process because it is a lower risk device and does not need the exemption. We are using the 510(k) premarket notification process with communication to the FDA using the pre-submission program. Similarly, the FDA Fast Track is only used for the drug approval process, and HeartSentry is a medical device. For HeartSentry, the 510(k) process is the most expeditious path available.
When do you anticipate FDA clearance?
Based on our strategic plan, our target to obtain FDA clearance for the professional HeartSentry product is late 2018 or early 2019. We have engaged with the FDA under pre-submission correspondences to obtain their input prior to starting our clinical trials and are on-track to submit our 510(k) application once we have compiled the required clinical data.
Do you have a prototype?
We have finished with the prototype phase and are currently in clinical testing of the first generation HeartSentry device intended for clinical study use.
When will the final product be completed?
The clinical trial product is available now and is currently in use. We are targeting a 2019 launch with a fully commercial ready product.
Where do you plan on manufacturing the product; in the U.S. or Asia?
Currently we are manufacturing the units in the United States and as we ramp up our commercial activity we will continue to evaluate cost-efficient manufacturing options.
How long does it take to measure a reading from the HeartSentry device?
Currently the test takes about ten minutes in a clinical trial setting, but we aim to lower the time to roughly 5 minutes per test as we enter the marketplace.
Is LNB the only company that does this?
Other companies and researchers have attempted to create devices like this, but none have been as simple and easy to use as HeartSentry.
How exactly does it work? How does it take its measurements?
The HeartSentry measures endothelial function by providing an external stimulation to the cardiovascular system and measuring the response.
How is this different than taking blood pressure?
In simple terms, HeartSentry measures heart rate, blood pressure, and endothelial function score, which has been shown in prior clinical research studies to be a predictor of future cardiovascular events. Blood pressure is the pressure of the blood in the circulatory system, often measured for diagnosis since it is closely related to the force and rate of the heartbeat and the diameter and elasticity of the arterial walls. Endothelial dysfunction can be defined as reduced bio-availability of Nitric Oxide (NO) which plays many roles in maintaining vascular health, most importantly its role in vasomotion. Hence, endothelial dysfunction is defined as an impairment of endothelium dependent vasodilation and a key factor of predictive assessment.
Are you planning to sell to other markets than the U.S.?
Our intention currently is to initially focus on the U.S. domestic market, but we are considering other international market approvals, including but not limited to Canada, Europe and Asia.
When can you bring the product to market?
We are aiming for a 2019 limited launch of the HeartSentry, initially into the professional marketplace.
Will the clinical studies be published in a medical journal?
We have not yet chosen the medical journals to publish our results in, but we are committed to being a part of the peer reviewed scientific process.
We take very seriously all patient privacy laws in the design, development, and deployment of our products, including HIPAA (Health Information Portability and Accountability Act).