Does your product/s require FDA approval?

Yes, we will require "FDA 510K Clearance" as a Class II device. This is a much shorter process than what most think of when they hear the letters FDA. Class II devices simply have the requirement of proving similarity to a currently marketed device. However, we have an even further abridged process compared to most undergoing the 510K process as the FDA has provided guidance documents that outline the exact studies and data required for our devices - No in-human studies are required!

Why no update? You are oversubscribed. You should close this round. So people can find out if they got in or not.

We are working with the closing team at WeFunder as we speak!

What will the money from round be used for. When will you begin production/ have a product for sale? When do you expect to be profitable? Will you need to raise more money after this?

The money for this round will go to developing manufacturing processes to produce FDA testable devices, as well as initiate the FDA process via bench testing of our devices. We anticipate having our single use product reach marketability status in Q4 2023, although this will depend on FDA timelines. We expect to be profitable once our single use device has been market integrated for 2-3 years. We will look to raise an additional $1M at our next round to scale production of devices and initiat...

How and where will the product be made. I am guessing you will be outsourcing manufacturing.

We are working with 3rd party, domestic (U.S) manufacturers. Devices will be produced by plastic injection molding.

Love Lifesciences

Revolutionizing the injection experience. Ensuring patients Love Life.

lovelifesciences.com

Overland Park, KS

Technology B2C Health & Fitness

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