- Cormedix is a Biotech company that primarily focuses on the Prevention of Catheter Related Blood infections with their leading Product Defencath. Catheter Related Blood Infections plagues the End Stage Kidney Disease population. According to the National Institute of Diabetes and Digestive and Kidney Diseases institute, nearly 808,000 people suffer from this ailment, and approximately 69% are on dialysis. (https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease#:~:text=Nearly%20808%2C000%20people%20in%20the,31%25%20with%20a%20kidney%20transplant.))
- Defencath is a catheter lock solution that eliminates gram positive and gram negative bacterial infections that develop within the catheter. It is composed of a solution of taurolidine and heparin that effectively reduces the CRBIS events in this vulnerable population. However, this population has a catheter that is surgically implanted into the patient, and it’s called, “a Central Venous Catheter.” This type of catheter is placed near a large central vein most commonly, internal jugular or subclavian or femoral. In layman terms, it’s placed near the patient’s heart, in a large vein to administer medication or to administer hemo-dialysis.
The results of their Lock-It 100 Study, had an efficacy rate of .0006 with a 71% Reduction in CRBIs compared to the control. This was so significant that the phase three study was halted. (https://pubmed.ncbi.nlm.nih.gov/37678222/). You can find more specific information regarding Catherter Related Blood infections on the Company’s website with their most recent deck here. ( https://cormedix.com/wp-content/uploads/2023/03/CorMedix-Corp-Presentation_1-7-23.pdf)
As of November 15, 2024 Cormedix received a NDA approval for the Limited Population of adult patients affected by kidney failure.( https://cormedix.com/cormedix-inc-announces-fda-approval-of-defencath-to-reduce-the-incidence-of-catheter-related-bloodstream-infections-in-adult-hemodialysis-patients/#:~:text=About%20CorMedix&text=DefenCath%20has%20been%20designated%20by,address%20an%20unmet%20medical%20need.))
Moreover, Cormedix Secured J-Codes for In-patient and out-patient settings, Jan 30, 2024 and April 9, 2024. (https://cormedix.com/cormedix-inc-announces-commercial-and-reimbursement-updates/) and(https://cormedix.com/cormedix-inc-announces-commercial-agreement-with-arc-dialysis-llc/)
Cormedix also secured TDAPA reimbursement from CMS for the out-patient setting on April 19, 2024. (https://cormedix.com/cormedix-inc-announces-cms-grants-tdapa-to-defencath/) Lastly, Cormedix Celebrated it’s commercial launch for the in-patient setting on April 15, 2024. (https://www.globenewswire.com/news-release/2024/04/15/2862768/0/en/CorMedix-Inc-Announces-U-S-Inpatient-Commercial-Availability-of-DefenCath-Taurolidine-and-Heparin.html)
Why is Cormedix a Deep Value opportunity to add to your portfolio today, while it’s trading as of Apr 19, 2024, at 5.20 per share at close. CEO Joe Todisco currently owns 352,000 shares, and added to his position with approximately 13,561 shares on March 13, 2024 at $3.74. Additionally, other insiders have not sold any shares over the past few years. I heavily weight insider ownership when the Officers heavily own shares, whether awarded or granted in lieu of payment. You can see all insider holdings here, (https://www.nasdaq.com/market-activity/stocks/crmd/insider-activity).
The institutional ownership owns about 33.94% of total shares on the open market, with the leading institution being Blackrock Inc., at 3,507,695 million shares held as of 12/31/2023. Numora Holdings Inc, comes in second at 2,946,552 million shares, then Vanguard at 2,825,335 million shares held. Coming in at 4th Place is Elliot Investment Management L.P., at 1,550,523 million shares held. For additional Institutional ownership see, (https://www.nasdaq.com/market-activity/stocks/crmd/institutional-holdings)
How does Defencath work and what are the projected vials to be sold? Cormedix projects about 3,400,000 million vials to be sold on the in-patient side and over 37 million vials on the out-patient side. This growth potential is HUGE! Well, with such volume, you’re probably wondering how the product exactly works. Every time a patient receives hemo-dialysis the catheter must be flushed with the Defencath solution before and after. That is approximately two vials per patient at least three times a week. The hemo-dialysis out-patient population is roughly about 550,000 people.
Cormedix plans, and is on tract, to launch defencath for the out-patient Setting on July 1, 2024.
Cormedix plans on expanding it’s usage and application of Defencath to other populations that already have CVCs. One example is Oncology.
Current short Interest as of March 31,2024 is 34 million dollars or approximately 8, 200,000 million shares shorted.
Disclosure I own contracts, exp June 2024, and I own approximately 4,000. Shares.
The projected market impact of this stock is incredible. And Understanding the product shows the extreme value it holds.
Good Luck!
This is not Trading advice, this just my opinion about Cormedix.
