공시 • Jan 08
Humacyte, Inc. Announces Hospital Charge Data Showing High Expense of Preventable Extremity Arterial Injury Complications
Humacyte, Inc. announced the results of a five-year retrospective analysis of hospital charges, payer costs, and healthcare resource utilization in patients with extremity arterial injury. The average hospital charge for extremity arterial injury repair during initial hospitalization was $316,600 per patient, and amputations and infections increased the average hospital charge per patient by $492,986 and $589,921, respectively. Humacyte’s Symvess (acellular tissue engineered vessel) has consistently demonstrated low rates of conduit infection and high rates of limb salvage in the treatment of extremity arterial injury. Data from two linked databases (Premier Inc. Healthcare Database and Inovalon all-payer claims database) included hospital charges and reimbursed costs in 964 adult patients with extremity arterial injuries that required surgical repair. Patients undergoing extremity arterial injury repairs using autologous vein, synthetic grafts, and other biological conduits were included, from 2018-2023. All data were collected prior to Food and Drug Administration approval of Symvess for extremity arterial injury repair and so reflect healthcare economics prior to Symvess commercialization. Healthcare costs were analyzed using logit and generalized linear models. The extremity arterial injury patient cohort had an average age of 36.5 years, and 26% were treated with conduits other than autologous vein. The average hospital charge for extremity arterial injury repair during initial hospitalization was $316,600, and the average reimbursed cost was $75,947. Preventable complications had enormous impacts on hospital charges, in particular graft infection, amputation, and rhabdomyolysis (severe ischemic damage to muscles). However, incremental reimbursement for these complications was substantially less than the increased hospital charges. Vascular graft infection resulted in an average of $589,921 in additional hospital charges, and the average reimbursed cost was $84,598. Amputation resulted in an average of $492,986 additional hospital charges, and the average reimbursement was $116,611. Symvess offers an alternative to the high costs of complications from extremity arterial injury that occur when vein is not feasible for repair. As previously reported in JAMA Surgery, in clinical study Symvess’s rate of infection was one-ninth that of synthetic graft historical controls, and Symvess’s amputation rate was one-fifth that of historical controls. Recently published positive three-year results from the V005 Phase 2/3 study of Symvess in extremity arterial injury repair represent the first-ever prospective long-term data in traumatic arterial repair using an off-the-shelf biologic conduit. Extremity arterial injury wounds are challenging for surgeons to treat, and autologous vein grafts have traditionally served as the standard of care due to their durability and low infection rates. However, autologous grafts are not always feasible in trauma settings where veins are damaged or there is little time to harvest - as evidenced by the fact that 26% of reported repairs of such injuries are not performed with vein. Symvess is designed to be immediately available off-the-shelf — saving critical surgical time in emergency situations — and has also consistently demonstrated low rates of infection and high rates of limb salvage. INDICATION Symvess is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. IMPORTANT SAFETY INFORMATION BOXED WARNING: GRAFT FAILURE Loss of Symvess integrity due to mid-graft rupture or anastomotic failure can result in life threatening hemorrhage. CONTRAINDICATIONS DO NOT use Symvess in patients who have a medical condition that would preclude long-term antiplatelet therapy (such as aspirin or clopidogrel) after resolution of acute injuries. WARNINGS AND PRECAUTIONS Graft Rupture Vascular graft rupture has occurred in patients treated with Symvess. Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture such as bleeding, pain and swelling in the extremity, or signs of extremity ischemia. Anastomotic failure has occurred in patients treated with Symvess. In clinical studies of Symvess, anastomotic failure occurred within the first 36 days post-implantation. Monitor patients for signs of anastomotic failure such as pain and swelling at the surgical site, decreasing hemoglobin or other signs and symptoms of bleeding. Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure such as bleeding, swelling or worsening pain at the surgical site or changes in color of overlying skin. Thrombosis has occurred in patients treated with Symvess. In clinical trials of Symvess, patients received antiplatelet therapy following implantation of Symvess to reduce the risk of thrombosis. The risk of thrombosis may increase in patients who discontinue antiplatelet therapy. Anti-platelet therapy is recommended following treatment with Symvess. Transmission of Infectious Diseases Symvess is manufactured using cells and reagents that may transmit infectious diseases or infectious agents. The cells used in the manufacture of Symvess are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum). The cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma. While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and the cause of a rare fatal condition in humans called variant Creutzfeldt-Jakob disease. No transmissible agent infections have been reported during clinical testing. ADVERSE REACTIONS The most common adverse reactions (occurring at = 10%), were vascular graft thrombosis, pyrexia (fever) and pain.
