Full Press Release Details
CytoSorbents Issues Stockholder Letter and
Fourth Quarter and Full Year 2022 Revenue
Cumulative CytoSorb treatments surpassed 195,000.
Q4 2022 product sales rebounded from Q3 2022 low. Adjusted for constant currency, Core non-COVID 2022 product sales were within 5% of
that achieved in 2021 and greater than 30% increased from pre-pandemic 2019
PRINCETON, N.J., January 31, 2023 - CytoSorbents
Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery
using blood purification via its proprietary polymer adsorption technology, issues a stockholder letter from its Chief Executive Officer,
Dr. Phillip Chan, and announces preliminary unaudited fourth quarter 2022 and full year 2022 results ahead of filing its Form 10-K.
Preliminary Unaudited Full Year 2022 Results
Preliminary Unaudited Q4 2022 Results
to report fully-audited financial results for Q4 2022 and full year 2022 on Thursday, March 9, 2023, with a conference call held
at 4:30PM ET. Further details for the earnings call will be provided at a later date.
CytoSorbents 2023: Eyes on the Prize
Dear Stockholders and Friends,
Before I begin, I thought it would be helpful
to pause and take stock of where CytoSorbents stands today. In short, we are a NASDAQ-traded medical device company that generated total
revenue of approximately $34.7M in 2022, primarily from international sales of our flagship product, CytoSorb , a unique therapy
that is E.U. approved for many life-saving applications in the multi-billion dollar markets of critical care and cardiac surgery. CytoSorb
has demonstrated its clinical value through 10 years of commercialization and nearly 200,000 treatments administered across 75 countries
around the world. In addition, we are working to enter the U.S. and Canadian markets for the first time with a second product, DrugSorb -ATR,
intended to reduce serious bleeding complications from cardiothoracic surgery associated with the blockbuster blood thinning drug, Brilinta
(AstraZeneca). We anticipate completing enrollment of our pivotal STAR-T registration trial this summer and if positive, intend to file
for FDA and Health Canada marketing authorization of DrugSorb-ATR following study completion. We closed 2022 with a strong cash balance
of $23.8M, and a grant contract backlog of approximately $11.5M, primarily to fund the development of HemoDefend-BGA for Universal Plasma,
another potentially major product in the queue.
We believe our value proposition is unique and
compelling, particularly in light of the major unmet medical needs that our products address globally, our high margin "razorblade"
business model, the validation of our technology by our customers, strategic partners, and government funding agencies, and the potential
proximity of opening and driving sales in the U.S., the largest medical device market in the world, with the potential to significantly
accelerate our sales growth and profitability.
1. Opening the U.S. and Canadian Markets
Antithrombotic, or "blood thinning,"
medications are among the most widely prescribed drugs in the world, with millions of people on these agents to reduce the risk of heart
attack and stroke. However, patients taking these medications have a higher tendency to bleed, sometimes fatally, particularly when undergoing
urgent surgery, suffering an acute injury, or developing a spontaneous bleeding event such as a hemorrhagic stroke or gastrointestinal
We are in the midst of the pivotal U.S. and Canadian
STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial, designed
to support FDA and Health Canada marketing approval for DrugSorb -ATR to reduce the risk of perioperative bleeding in patients undergoing
cardiothoracic surgery potentially caused by Brilinta (ticagrelor). DrugSorb-ATR has already received two FDA Breakthrough Device
Designations, one to remove Brilinta, and the other to remove direct oral anticoagulants such as Xarelto (Bayer, Janssen) and Eliquis
(Pfizer, BMS), highlighting the lack of effective approved or cleared therapies in the U.S. to deal with the bleeding risk in surgical
patients. Based on actual data on numbers of U.S. and Canadian patients on Brilinta needing urgent cardiothoracic surgery each year,
we estimate the immediate combined total addressable market for DrugSorb-ATR in these two countries is approximately $300-350M currently,
and expected to potentially double as Brilinta becomes generic in 2024. We are already working with many of the leading cardiac
surgery centers and surgeons in both the U.S. and Canada that have historically been instrumental in driving innovation in the cardiac
In 2023, our goal is to successfully complete
the STAR-T trial, finalize our data analysis, and file for U.S. FDA and Health Canada regulatory approval. We believe this would be a
game changing win for our company and have been working to put the pieces in place to achieve this. Most recently, we have:
Patient enrollment in STAR-T continues to meet
expectations. We expect to reach the second milestone of 80 patients enrolled this spring, which will trigger the next unblinded data
review by the DSMB, and to complete enrollment of all 120 patients this summer, with database lock and topline data expected shortly
thereafter. If positive, FDA and Health Canada regulatory submissions are planned upon the completion of the trial.
Preparing for Commercialization of DrugSorb-ATR
Meanwhile, we have developed a detailed launch
and commercialization strategy for DrugSorb-ATR and are pursuing our pre-commercial development in parallel to the clinical study. A
key area of focus is how DrugSorb-ATR will be funded. Based upon a number of health economic analyses done in the U.K., Germany, and
here in the U.S., the value proposition of DrugSorb-ATR to reduce bleeding complications and their associated costs is dominant, even
in the absence of dedicated reimbursement. With approval, we expect rapid adoption under current cardiac surgery payment bundles. That
said, the STAR-T randomized, controlled trial is designed to provide valuable health economics data to support market pricing and standard
reimbursement of DrugSorb-ATR from both private and government insurers such as Centers for Medicare and Medicaid Services (CMS), where
we believe the cost-benefit message is very compelling.
Although we feel very comfortable with the conventional
path to obtain reimbursement for DrugSorb-ATR, interestingly, there may soon be another alternative avenue to obtain CMS reimbursement
that will only be available to a select group of FDA-approved Breakthrough Devices. We have previously discussed how in January 2021,
CMS announced the "Medicare Coverage for Innovative Technologies (MCIT)" rule, that was designed to spur innovation in the
medical device industry by offering up to four years of automatic reimbursement for approved or cleared FDA Breakthrough Devices. This
would have been very relevant to DrugSorb-ATR as a Breakthrough Device, as many patients on blood thinners who require cardiothoracic
surgery are in the targeted Medicare population. Unfortunately, CMS rescinded the rule in late 2021, citing needed improvements
to ensure safety, efficacy, and relevance in Medicare patients. In the wake of this disappointing news, leading researchers at Stanford
University, including Dr. Joshua Makower, published a paper entitled "The Need for Accelerated Medicare Coverage
of Innovative Technologies: Impact on Patient Access and the Innovation Ecosystem." In the paper, CytoSorbents and DrugSorb-ATR
were selected as one of four highlighted Breakthrough technologies, among all other FDA Breakthrough Devices, that exemplified the importance
of the MCIT rule to the Medicare population.
Thankfully, there is broad bipartisan support
of the MCIT rule, and a modified version of it is included in the proposed CURES 2.0 Act legislation. In addition, in early
2022, CMS announced a new initiative called "Transitional Coverage for Emerging Technologies (TCET)" as a potential replacement
for MCIT. TCET is supported by AdvaMed (Advanced Medical Technology Association) - the world's largest medical technology
association representing device, diagnostics, and digital technology manufacturers who issued a similar letter supporting a proposed
TCET rule in August 2022.
In an article entitled, "A Vision of
Medicare Coverage for New and Emerging Technologies - A Consistent Process to Foster Innovation and Promote Value" published
in the October 13, 2022 edition of the Journal of the American Medical Association (JAMA), Dr. Lee Fleisher and Jonathan Blum,
Centers for Medicare & Medicaid Services (CMS), said that CMS is "committed to making sure Medicare beneficiaries are
able to access emerging technologies" and announced plans to develop a new expedited Medicare reimbursement coverage pathway for
new and innovative medical devices that are relevant to the Medicare population.
At a Medtech Conference panel in October 2022,
Tamara Syrek Jensen, director of the CMS Coverage and Analysis Group, stated that CMS plans to issue a proposed TCET policy by April 2023
and stated "We will have a proposed [rule] out by April of 2023, that is a big priority for my crew." This was reiterated
at the November 9-10, 2022 Medical Device Manufacturers Association (MDMA) meeting featuring CMS officials where in a meeting synopsis,
a key takeaway was that "TCET is still a CMS priority and policy development is ongoing, expected timeline for the proposed
rule is early 2023."
In a press release and open letter
to CMS Administrator Chiquita Brooks-LaSure on December 16, 2022, members of Congress urged CMS to issue a proposed rule to
streamline Medicare beneficiaries' access to innovative medical devices" and stated, "We firmly believe a successful
implementation of a TCET rule should include an independent transitional coverage pathway for breakthrough devices that have been
proved safe and effective by the FDA."
we believe DrugSorb-ATR, as an FDA Breakthrough Device whose target population comprises many patients 65 years of age
and older in the Medicare population, could be well-suited to a proposed CMS TCET policy. We are encouraged by the continued prioritization
of this program by CMS and will continue to follow the progress closely. If it becomes a reality, we will investigate this as an alternate