DURHAM, N.C. - Humacyte, Inc. (NASDAQ:HUMA), a biotech firm specializing in bioengineered human tissues, announced today the approval of four new ICD-10-PCS codes by the U.S. Centers for Medicare & Medicaid Services (CMS).
These codes, effective from October 1, 2024, are designated for procedures involving the replacement of arteries in the upper and lower extremities using the company’s Human Acellular Vessels (HAVs), now also known as "acellular tissue engineered vessels" (ATEVs).
The CMS ICD-10 Coordination and Maintenance (C&M) Committee's issuance of these codes is a crucial step for Humacyte as it moves towards the submission of a New Technology Add-on Payment (NTAP) application to CMS later in 2024.
The ICD-10-PCS codes are used for accurate tracking of inpatient procedures and are essential for hospitals and insurers for data collection, payment, and monitoring purposes.
The codes cover the following procedures:
- X2R50WA: Replacement of Right Upper Extremity Artery using Bioengineered HAV, Open Approach.
- X2R60WA: Replacement of Left Upper Extremity Artery using Bioengineered HAV, Open Approach.
- X2R70WA: Replacement of Right Lower Extremity Artery using Bioengineered HAV, Open Approach.
- X2R80WA: Replacement of Left Lower Extremity Artery using Bioengineered HAV, Open Approach.
The ATEV is designed for urgent arterial repair, especially when synthetic grafts are unsuitable and autologous vein use is not possible. It is intended to be an off-the-shelf solution, potentially saving time for surgeons and improving patient outcomes. Humacyte's ATEV has been used in over 1,200 patient-years globally in clinical trials for various vascular applications.
The company’s Biologics License Application (BLA) for the ATEV is currently under Priority Review by the FDA, with a decision expected by August 10, 2024. This submission is supported by Phase 2/3 clinical trial results and the treatment of wartime trauma injuries in Ukraine, where the ATEV demonstrated promising results compared to traditional synthetic grafts.
Humacyte's ATEV is an investigational product and has not yet been approved for sale by the FDA or any other regulatory agency. The information in this article is based on a press release statement from Humacyte, Inc.
In other recent news, biotechnology company Humacyte, Inc. has reported significant developments. The company has announced a reshuffle of its board of directors, including the election of six Class III directors and the ratification of PricewaterhouseCoopers LLP as its independent auditor. These changes were supported by a nearly unanimous vote from stockholders.
On the financial front, Humacyte disclosed a net loss of $31.9 million for the first quarter of 2024. Despite this, the company has secured $63 million in funding and ended the quarter with $115.5 million in cash and cash equivalents.
In addition, Humacyte's Biologics License Application for the Humacyte Vascular Access Graft (HAV) has been accepted by the FDA, granting it Priority Review. The company is now actively engaging with payers and assembling a sales team in preparation for a potential market launch. These recent developments highlight Humacyte's ongoing efforts to commercialize its flagship product, the HAV.
InvestingPro Insights
As Humacyte, Inc. (NASDAQ:HUMA) advances with its Human Acellular Vessels (HAVs), investors are closely monitoring the company's financial health and stock performance. According to InvestingPro, Humacyte holds a market capitalization of approximately $839.54 million USD, reflecting the market's valuation of the company's potential. However, the firm's P/E ratio stands at -6.99, and when adjusted for the last twelve months as of Q1 2024, it dips further to -8.13, indicating that the market has yet to see profitability from Humacyte.
Despite these challenges, the company's stock has shown remarkable resilience and growth, with a 117.59% price total return over the last three months and an even more impressive 128.16% over the past six months. This growth trajectory is also reflected in the year-to-date price total return, which has surged to 148.24%. These metrics underscore the volatile but potentially rewarding nature of Humacyte's stock as highlighted by InvestingPro Tips, which also notes that the company's liquid assets exceed its short-term obligations, providing some financial stability.
Investors considering Humacyte should be aware of the company's significant Price / Book multiple of 32.1 as of the last twelve months leading to Q1 2024, which may suggest a premium valuation compared to its tangible assets. Additionally, one of the InvestingPro Tips points out that Humacyte does not pay a dividend to shareholders, which may be a consideration for those seeking income-generating investments.
For those interested in a deeper dive into Humacyte's financials and stock performance, InvestingPro offers additional insights. With a subscription, users can access more than 10 InvestingPro Tips tailored to HUMA. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and unlock a comprehensive analysis that could inform your investment decisions.
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