Frequently Asked Questions (FAQs)

Yes, we signed the Medicaid National Drug Rebate Agreement with CMS.

Yes, we signed the Medicaid National Drug Rebate Agreement with CMS and 340B-eligible entities can order Lasix ONYU under the rebate terms.

SQ Innovation has set its wholesale acquisition cost (WAC) for a Treatment Kit at $475.  A patient typically needs multiple treatment kits for the treatment of an episode of edema in chronic heart failure.    Patients hospitalized for the treatment of edema in chronic heart failure normally receive 500-1000mg of furosemide intravenously during a 4-7 day hospital stay.  This is equivalent to approximately 6-12 doses of  Lasix ONYU.   Milder cases may require fewer units.

For Lasix ONYU treatment, a Reusable Unit is also required.   This is the motorized component that makes the Lasix ONYU Infusor work.  See Instructions for Use for more information on the Reusable Unit and how to operate the Lasix Infusor.    The Reusable Unit can deliver 48 Lasix ONYU treatments after which it can be recycled.   So only ONE Reusable Unit is needed when starting treatment with Lasix ONYU.  SQ Innovation has set the WAC for the Reusable Component at $299.00.   See Prescribing Information and Instructions for Use before using Lasix ONYU.

The price of Lasix ONYU to be paid by a buyer is set by those who sell it.   For patients, how much they need to pay is determined by their insurance provider. Check with your health insurer or prescription drug plan.

SQ Innovation did payor research and frequently meets with payors.   We also did health-economic analyses.  It is not always easy to identify patients for whom admission is imminent - such as having a risk of 40% or more to be admitted within 72hrs.   We did the math and factored in that sometimes patients may be prescribed Lasix ONYU who did not need it to prevent or reduce a hospital stay.   At our affordable price level, everyone wins, including the payers - Medicaid, Medicare and commercial insurance carriers.

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 FDA Approval on October 7, 2025.   Lasix ONYU is commercially available in the US.

We estimate completing CE marking under the MDR in Europe in early 2026 and aim for EMA approval in early 2027.

No, Lasix ONYU is regulated as a pharmaceutical product and was approved under a New Drug Application (NDA).  To be precise, this was a 505(b)(2) NDA, which is an NDA that partially relies on information already known to the FDA.  The FDA approved its first furosemide products in 1964 and the FDA has accumulated a lot of information about furosemide over the 60 years of use.  Lasix ONYU includes the Infusor.  Although the Infusor requried a full medical device development and testing program, this information was included in the NDA and there was no separate device filing such as a 510(k).

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.   So the development and testing program are very similar, these are regulated in a different way.