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Condensed Balance Sheets - USD ($)
Sep. 30, 2025
Dec. 31, 2024
Current assets:    
Cash and cash equivalents $ 4,569,038 $ 3,451,761
Accounts receivable, net 572,199 488,373
Inventory 5,783,974 3,046,323
Prepaid and other current assets 1,321,689 1,035,993
Total current assets 12,246,900 8,022,450
Property and equipment, at cost:    
Leasehold improvements 1,238,886 1,238,886
Office equipment 78,155 60,921
Furniture and fixtures 417,876 417,876
Machinery and equipment 3,283,672 2,856,740
Construction in progress 687,462 762,445
Property and equipment, gross 5,706,051 5,336,868
Less accumulated depreciation (3,956,987) (3,740,769)
Net property and equipment 1,749,064 1,596,099
Long-term assets:    
Lease right-of-use assets, net 1,419,345 1,805,543
Intangible assets, net of accumulated amortization 130,041 65,918
Other long-term assets 744,803 954,992
Total long-term assets 2,294,189 2,826,453
Total assets 16,290,153 12,445,002
Current liabilities:    
Accounts payable 2,173,883 1,419,044
Accrued expenses 1,028,461 1,151,049
Note payable 276,489 0
Convertible notes payable, net (including related parties) 6,507,354 5,406,228
Clinical holdback – current portion 60,543 88,581
Operating lease liabilities – current portion 494,954 517,967
Total current liabilities 10,541,684 8,582,869
Long-term liabilities:    
Clinical holdback – long-term portion 43,955 39,611
Lease liabilities – long-term portion 1,148,263 1,518,100
Total long-term liabilities 1,192,218 1,557,711
Total liabilities 11,733,902 10,140,580
Commitments and contingencies
Stockholders’ equity:    
Common stock, $0.001 par, 200,000,000 authorized,47,419,596 shares issued and 47,302,373 outstanding as of September 30, 2025; and 23,473,149 shares issued and 23,355,926 outstanding as of December 31, 2024 47,420 23,473
Treasury stock, 117,223 common Shares (60,000) (60,000)
Warrants 6,727,334 1,860,008
Additional paid-in-capital 139,717,336 127,679,198
Accumulated deficit (141,875,839) (127,198,257)
Total stockholders’ equity 4,556,251 2,304,422
Total liabilities and stockholders' equity $ 16,290,153 $ 12,445,002