Centers for Medicare & Medicaid Services (CMS) Issues ICD-10-PCS Codes for Humacyte’s Human Acellular Vessel™ (HAV™)
Humacyte announced the issuance of four new ICD-10-PCS codes by CMS, effective October 1, 2024, for replacing arteries using Humacyte’s Human Acellular Vessel (HAV). These codes cover procedures for both upper and lower extremities. Humacyte is progressing towards a New Technology Add-on Payment (NTAP) application to CMS. Additionally, Humacyte's FDA Priority Review BLA submission for vascular trauma treatment, supported by Phase 2/3 clinical trial results and real-world use in Ukraine, awaits a decision on August 10, 2024. The HAV, now dubbed the 'acellular tissue engineered vessel' (ATEV), is designed for urgent arterial repair and has shown higher patency rates and lower infection rates compared to synthetic grafts. The ATEV is still investigational and not yet FDA-approved.
- Issuance of four new ICD-10-PCS codes by CMS for Humacyte's HAV.
- Codes effective from October 1, 2024, facilitating data collection and hospital payments.
- Progress towards NTAP application to CMS planned for later in 2024.
- FDA Priority Review for BLA submission with decision expected on August 10, 2024.
- Positive Phase 2/3 trial results and real-world use in Ukraine supporting BLA submission.
- HAV demonstrated higher patency rates and lower infection rates compared to synthetic grafts.
- Humacyte's manufacturing facilities capable of commercial-scale production.
- ATEV is still investigational and not yet FDA-approved.
- Dependence on FDA approval for BLA submission on August 10, 2024.
- Potential delays or negative outcomes in the regulatory process could impact business.
Insights
The issuance of new ICD-10-PCS codes for Humacyte’s Human Acellular Vessel (HAV) is a significant development for the healthcare sector. These codes, set to be effective from October 1, 2024, are pivotal for the commercialization and adoption of HAVs. Medical professionals can now accurately classify and track procedures involving HAVs, which are important for managing vascular trauma. The codes are particularly meaningful given that HAVs offer a universal, off-the-shelf solution that can be used when synthetic grafts are unsuitable or autologous veins are not feasible.
From a clinical perspective, HAVs have demonstrated improved patency rates and lower infection rates compared to synthetic alternatives. This can potentially revolutionize emergency vascular repair, especially in trauma settings where time is critical. The positive clinical trial results and real-world use, such as in Ukraine, underscore HAV’s potential efficacy and safety, which is a positive indicator for eventual FDA approval.
For investors, the issuance of ICD-10-PCS codes and the upcoming FDA decision on Humacyte’s Biologics License Application (BLA) are key milestones. Obtaining these codes paves the way for Humacyte to apply for New Technology Add-on Payments (NTAP), which can financially benefit hospitals adopting HAVs. This aligns with Humacyte's strategy to make HAVs commercially viable and accessible, potentially driving revenue growth.
The priority review status and the pending PDUFA date of August 10, 2024, indicate that Humacyte’s product is on the fast track for regulatory approval. Continued positive news could lead to an uptick in stock price as the market anticipates future earnings from HAV sales. However, investors should remain cautious until FDA approval is granted, as any regulatory setbacks could impact stock performance.
Additionally, Humacyte’s capability to produce HAVs at a commercial scale is an important factor. This ensures that they can meet the demand post-approval, which bodes well for long-term financial health.
The classification of Humacyte’s HAV with new ICD-10-PCS codes will likely enhance market penetration and adoption rates within hospitals. This move is critical for widespread clinical usage, facilitating insurance reimbursements and streamlining administrative processes. Market acceptance is further bolstered by the positive clinical results and real-world evidence supporting HAV’s efficacy.
Potential market growth is substantial, given the unmet need in vascular trauma repair and other related applications. The ATEV’s off-the-shelf availability addresses a significant clinical gap, positioning it favorably against traditional synthetic grafts and autologous veins. If FDA approval is granted, HAV could become a go-to solution for vascular repairs, especially in urgent and complex cases.
However, challenges remain, including educating the medical community and integrating HAV into existing clinical protocols. Humacyte’s marketing strategy and partnerships with hospitals will be vital to overcoming these barriers and achieving market penetration.
– Four unique ICD-10-PCS codes, effective October 1, 2024, for replacement of arteries in the upper and lower extremities using Humacyte’s HAV –
– BLA submission under Priority Review by FDA for the treatment of vascular trauma, supported by Phase 2/3 clinical trial results and real-world use treating wartime trauma injuries in Ukraine –
DURHAM, N.C., June 17, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, Human Acellular Vessels (HAVs) at commercial scale, today announced the issuance of four new ICD-10-PCS codes by the U.S. Centers for Medicare & Medicaid Services (CMS) ICD-10 Coordination and Maintenance (C&M) Committee. These codes, effective for hospital discharges beginning October 1, 2024, cover procedures for replacing arteries in the upper or lower extremities using Humacyte’s HAV. Humacyte also announced that, based on guidance from the Food and Drug Administration (FDA), the common (non-brand) name for the HAV will be the "acellular tissue engineered vessel" (ATEV).
The CMS ICD-10 C&M Committee issues ICD-10-PCS codes to facilitate accurate classification and tracking of procedures. The ICD-10-PCS is a classification for procedures performed during inpatient hospital admissions1. The codes are widely used by hospitals and insurers to support data collection, payment, and monitoring. Obtaining these codes marks a significant milestone as Humacyte advances toward submission of a New Technology Add-on Payment (NTAP) application to CMS planned for later in 2024. Obtaining an ICD-10-PCS code is necessary to file an NTAP application.
The newly issued codes are:
X2R50WA: Replacement of Right Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10
X2R60WA: Replacement of Left Upper Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10
X2R70WA: Replacement of Right Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10
X2R80WA: Replacement of Left Lower Extremity Artery using Bioengineered Human Acellular Vessel, Open Approach, New Technology Group 10
The ATEV is designed for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. ATEVs, which are bioengineered human tissues, are under investigation as universally implantable vascular replacements that resist infection and do not require immune suppression. The ATEV is intended to be readily available – “off-the-shelf” – with the potential to save valuable time for surgeons, thereby improving patient outcomes and reducing complications. Humacyte has extensive experience with the ATEV, accumulating over 1,200 patient-years of worldwide use in clinical trials for vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The company’s manufacturing facilities are capable of producing ATEVs at commercial scale to meet the potential needs of thousands of patients.
The Prescription Drug User Fee Act (PDUFA) date for the FDA’s regulatory decision on Humacyte’s Biologics License Application (BLA), is August 10, 2024. This is based on a Priority Review which was granted by the FDA. The BLA submission was supported by positive results from the V005 Phase 2/3 clinical trial, and real-world evidence from the treatment of wartime injuries in Ukraine. In these studies, Humacyte’s ATEV demonstrated higher patency (blood flow) rates and lower amputation and infection rates as compared to historic synthetic graft benchmarks.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial product candidates, a portfolio of ATEVs, are currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous (AV) access for hemodialysis, and peripheral artery disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s RMAT designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, the expected PDUFA date; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our ATEVs; our ability to successfully complete, preclinical and clinical trials for our ATEVs; the anticipated benefits of our ATEVs relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings, acceptances and approvals, including the BLA for our V005 clinical trial and the NTAP application to CMS; timing, scope, and rate of reimbursement for our ATEVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
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1 Centers for Medicare & Medicaid Services. (2024). ICD-10-PCS Official Guidelines for Coding and Reporting 2025. Retrieved from https://www.cms.gov/files/document/2025-official-icd-10-pcs-coding-guidelines.pdf
FAQ
What are the new ICD-10-PCS codes issued for Humacyte's HAV?
When will the new ICD-10-PCS codes for Humacyte's HAV be effective?
What is the FDA Priority Review decision date for Humacyte’s BLA submission?
What clinical results support Humacyte’s BLA submission?
What is the common name for Humacyte’s HAV as per FDA guidance?
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