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| MocaHeart--Courtesy of MocaCare |
Palo-Alto, CA-based MocaCare has raised $2 million to launch a tiny hand-held monitor that purports to evaluate cardiovascular health. The startup is aiming for a September launch of its device, MocaHeart, with its accompanying smartphone app with a price point of $149.99.
The device measures heart rate and blood oxygen level as well as a proprietary indicator called the Moca Index, which is a qualitative measurement of blood flow that is correlated to blood pressure. Despite the incorporation of this novel measure, the company says that its consumer health device does not require FDA clearance. But the company does plan to do so in the future--for use in a specific indication.
"MocaHeart is a consumer health electronics device that does not offer medical recommendations and it is not used to diagnose or treat a medical condition and therefore does not require FDA approval or clearance based on the FDA guidance for mobile medical applications,"MocaCare co-founder and COO Naama Stauber told FierceMedicalDevices. "MocaCare does plan to pursue FDA clearance in the future in order to enhance its offering using the data collected from MocaHeart for a clinical indication for use."
The company sees the MocaHeart device as a monitor that will be useful for adults "who need to monitor their everyday health," particularly those with "heart problems or high blood pressure," according to the company's site. High blood pressure affects almost one-third of American adults, with associated annual healthcare costs of almost $50 billion.
"The capital and strategic resources provided by the investment partnerships we announced today will take the introduction of the MocaHeart device to a whole new level." said MocaCare co-founder and CEO Dr. Daniel Wei-Chen Hong. "We have seen extremely strong interest in MocaHeart from the investment and medical community and look forward to bringing it to consumer audiences."
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| Smartphone showing Moca Index--Courtesy of MocaCare |
The app offers a numerical and color indication of the Moca Index from a low of 1 to a high of 5; the highest level indicates that immediate medical attention is required. The company sees this index as a target for improvement by MocaHeart users who consciously are improving their heart health via lifestyle choices including diet and exercise. The app can be used to track and share any resulting data.
The MocaHeart's design is award-winning and reflects the broader industry push to apply consumer design standards and aesthetics to medical devices. It measures 1 3/8 inches wide, 2 3/4 inches long, and 1/4 inch thick with a weight of about 0.7 ounces. The device comes in various colors and can be attached to the back of a smartphone via a case, for ease of use and access. The accessory pack including the case will be available by yearend.
Founded in 2013 with a manufacturing center in Taipei, MocaCare has raised over $4 million in total financing. It previously ran a proof-of-concept Kickstarter campaign that raised over $120,000, as well as garnered a seed financing. Singapore-based wearable tech and mobile health solutions fund JDMMobileInternetSolutionsPTE led the recent round, with participation by EMB International and Atom Health.
"There is a huge opportunity around the world to simplify the at home monitoring of cardiovascular health and we're excited to invest in MocaCare that is well placed to power this new resource to consumers and medical professionals," said EMB's Steve Huang.
- here is the statement