Frequently Asked Questions

Our formulation research started in the second half of 2018. Numerous novel strategies were tested to achieve the target concentration of 30mg/mL or higher. This research yielded three different promising formulations involving loop diuretics including furosemide.  These are all based on ingredients that are commonly used in pharmaceutical products and are generally considered safe.

In 2022 a patent was issued for the composition of the novel formulation we use with the Infusor.  A patent means it is distinctly different from other formulations before it. The standard formulation for furosemide is known as Furosemide Injection, USP. This has been, the standard furosemide injection product for human use since 1968. It is almost exclusively used for intravenous administration. Our novel formulation was specifically formulated for subcutaneous infusion by reducing the pH from alkaline to neutral and to increase the concentration.   The benefit of a higher concentration is that a small volume can be administered in a cost-effective manner. We also wanted a product that can be stored outside the refrigerator (room temperature) for 24 months.

We designed the infusor to reuse its electronic components for multiple treatments. The only part that needs to be discarded is the Disposable Unit. This unit consists of plastic components and a stainless-steel needle or cannula. It contains all the parts that come into contact with the drug during delivery, as well as those that are in direct contact with the body. For this reason, the Disposable Unit must be sterilized, much like medical syringes and other similar products. Radiation sterilization is the standard method used for these types of products.

Medical devices can be sterilized using various methods, including moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and others, such as chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide.

For those interested, the FDA website provide more information:

FDA: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices#why

The Infusor attaches to the abdominal skin with medical tape.   This is the same kind of tape that is used in hospitals and with the old-style adhesive bandages.   Getting something to stick to the body sounds easy.  However, there is much more to it than one might think.  Medical adhesive tapes use a form of glue known as acrylate adhesives.   These have been the standard for decades and are still considered the best for most applications.  Acrylate adhesives bond to the top layer of the skin.   As with other glues, after a short period of drying the bond is irreversible to the top layer of the skin.

Our Infusor is small and light and not to be used during swimming or bathing,   This allowed us to try a gentle adhesive.  We worked closely with 3M to select the most gentle adhesive for our Infusor.  3M is the largest manufacturer of medical adhesives and offers a broad range of medical tapes.  We tested the most gentle version of the series 3M offered.   It is the same adhesive used for other applications where easy removal without skin irritation is important.  The non-tackified medical tape we selected is used for temporary tattoos, under eye patches and medical use such as for around stoma.     All of these applications require minimal risk of irritation, skin damage and removal with the least amount of discomfort.   We know how much most people hate painful removal of medical tape and bandages. We are very pleased the most gentle 3M acrylate adhesive was able to hold the device in place during treatment.  This  avoids or minimizes any discomfort during removal.  This is another benefit of using a small volume and light Infusor.

We received Tentative Approval from the FDA in October of 2024.   Tentative Approval means the product meets all the requirements for approval for safety, effectiveness, labeling and manufacturing, but the product is not yet approved for sale.   Final approval can only be granted when market exclusivity granted to another company has expired in October of 2025.

We expect to submit for market authorization and CE marking in Europe in early 2025.

Products for subcutaneous infusion of drugs require a drug formulation that is suitable for this and a device to deliver it. Although the FDA has several options to regulate these, for new combinations the FDA often decides they want them regulated as a single, combined entity. In this case they are usually regulated as a drug and fall under the New Drug Application process. This is also the case for us. For those familiar with the device regulations this means there is not a separate 510(k) application for the device.

This is different from insulin pump devices. These are usually developed and commercialized independent of a specific insulin product. In this case the device is regulated under the 510(k) device regulations and the insulin products follow the biopharmaceutical regulations.

Even if there is no separate regulatory filing for the device, the FDA requires that the device component be developed, tested and manufactured in accordance with the strict device regulations. The device regulations are very different than the ones that apply to the drug component and companies must setup procedures and systems to support both.