Regulatory & Patents

Regulatory

The OCS Lung, OCS Heart and OCS Liver are all CE marked devices.

The following safety and performance information is for EU customers and patients, as required by EU medical device regulations:

OCS Lung

OCS Heart

OCS Liver

The OCS Lung is an FDA approved device for standard and expanded¹ criteria donor lungs. The OCS Heart is an FDA approved device for expanded² criteria donor hearts. The OCS Liver is an FDA approved device for DCD³ and DBD donor Livers.

1. Expanded criteria lungs is defined as donor lung pairs initially deemed unacceptable for procurement and transplantation based on limitations of cold static preservation.

2. Expanded criteria hearts is defined as donor hearts that are deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time).

3. DCD livers < 55 years old with < 30 mins warm ischemia time and macrosteatosis < 15%.

Patents

The following is a list of the 必赢亚洲™ Organ Care System™ (OCS™) patents.

Organ Care System (OCS) Lung

U.S. Pat. No. 6,046,046
U.S. Pat. No. 6,100,082
U.S. Pat. No. 8,420,380
U.S. Pat. No. 8,535,934
U.S. Pat. No. 8,585,380
U.S. Pat. No. 8,822,203
U.S. Pat. No. 9,055,740
U.S. Pat. No. 9,247,728
U.S. Pat. No. 9,462,802
U.S. Pat. No. 9,814,230
Australian Pat. No. 728233
Australian Pat. No. 2008260409
Australian Pat. No. 2009212725
Australian Pat. No. 2013216566
Australian Pat. No. 2014202736
Australian Pat. No. 2014256394
Australian Pat. No. 2015202735
Australian Pat. No. 2017204594
Austrian Pat. No. 2244773
Belgian Pat. No. 2244773
Belgian Pat. No. 3178319
Canadian Pat. No. 2713443
Canadian Pat. No. 2881613
Canadian Pat. No. 2899880
Canadian Pat. No. 3015816
Chinese Pat. No. 201310148246.9
Chinese Pat. No. ZL200980110231.5
Chinese Pat. No. ZL201310556156.3
Chinese Pat. No. ZL202011251518.4
Czech Pat. No. 2244773
Danish Pat. No. 2244773
Danish Pat. No. 3178319
European Pat. No. 2244773
European Pat. No. 3178319
French Pat. No. 2244773
French Pat. No. 3178319
German Pat. No. 2244773

German Pat. No. 3178319
Hong Kong Pat. No. 1192115
Hong Kong Pat. No. HK1150235
Hong Kong Pat. No. HK1238497
Irish Pat. No. 2244773
Irish Pat. No. 3178319
Israeli Pat. No. 207289
Israeli Pat. No. 247534
Israeli Pat. No. 282647
Israeli Pat. No. 290501
Israeli Pat. No. 299248
Italian Pat. No. 2244773
Italian Pat. No. 3178319
Japanese Pat. No. 5599322
Japanese Pat. No. 5746534
Japanese Pat. No. 5889861
Japanese Pat. No. 6144238
Japanese Pat. No. 6483594
Japanese Pat. No. 7186825
Japanese Pat. No. 7518142
Netherlands Pat. No. 2244773
Netherlands Pat. No. 3178319
New Zealand Pat. No. 586901
New Zealand Pat. No. 600702
New Zealand Pat. No. 603329
New Zealand Pat. No. 623220
New Zealand Pat. No. 709775
New Zealand Pat. No. 724681
New Zealand Pat. No. 739110
New Zealand Pat. No. 753880
Spanish Pat. No. 2244773
Spanish Pat. No. 3178319
Swedish Pat. No. 2244773
Swedish Pat. No. 3178319
U.K. Pat. No. 2244773
U.K. Pat. No. 3178319

Organ Care System (OCS) Heart

U.S. Pat. No. 6,046,046
U.S. Pat. No. 6,100,082
U.S. Pat. No. 7,572,622
U.S. Pat. No. 7,651,835
U.S. Pat. No. 8,304,181
U.S. Pat. No. 8,409,846
U.S. Pat. No. 8,465,970
U.S. Pat. No. 8,585,380
U.S. Pat. No. 9,055,740
U.S. Pat. No. 9,215,867
U.S. Pat. No. 9,301,519
U.S. Pat. No. 10,039,276
U.S. Pat. No. 10,194,655
U.S. Pat. No. 11,122,795
U.S. Pat. No. 11,570,985
U.S. Pat. No. 11,844,345
Australian Pat. No. 728233
Australian Pat. No. 2005294206
Australian Pat. No. 2008260409
Australian Pat. No. 2012216796
Australian Pat. No. 2013216566
Australian Pat. No. 2014256394
Australian Pat. No. 2016318622
Australian Pat. No. 2017254983
Australian Pat. No. 2019275587
Australian Pat. No. 2021215289
Austrian Pat. No. 3347084
Belgian Pat. No. 1768490
Belgian Pat. No. 3347084
Chinese Pat. No. ZL200580042038.4
Chinese Pat. No. ZL200880020749.5
Chinese Pat. No. ZL201210449227.5
Chinese Pat. No. ZL201310556156.3
Chinese Pat. No. ZL201680051905.9
Chinese Pat. No. ZL202110148261.8
Czech Pat. No. 3347084
Danish Pat. No. 1768490
Danish Pat. No. 3347084
European Pat. No. 1768490
European Pat. No. 3347084
French Pat. No. 1768490
French Pat. No. 3347084
German Pat. No. 1768490
German Pat. No. 3347084
Hong Kong Pat. No. 1101890
Hong Kong Pat. No. 1145942
Hong Kong Pat. No. 1185516
Hong Kong Pat. No. HK1252661

Hong Kong Pat. No. HK40055233
Irish Pat. No. 1768490
Irish Pat. No. 3347084
Israeli Pat. No. 182403
Israeli Pat. No. 211084
Israeli Pat. No. 249263
Israeli Pat. No. 253737
Israeli Pat. No. 257512
Israeli Pat. No. 258702
Israeli Pat. No. 273422
Israeli Pat. No. 278367
Israeli Pat. No. 298619
Israeli Pat. No. 300692
Israeli Pat. No. 280360
Italian Pat. No. 1768490
Italian Pat. No. 3347084
Japanese Pat. No. 5113522
Japanese Pat. No. 5462406
Japanese Pat. No. 5746534
Japanese Pat. No. 5889861
Japanese Pat. No. 5933666
Japanese Pat. No. 6625384
Japanese Pat. No. 6850108
Japanese Pat. No. 6895472
Japanese Pat. No. 6934005
Japanese Pat. No. 7288483
Japanese Pat. No. 7462689
Japanese Pat. No. 7496018
Netherlands Pat. No. 1768490
Netherlands Pat. No. 3347084
New Zealand Pat. No. 554543
New Zealand Pat. No. 580648
New Zealand Pat. No. 591524
New Zealand Pat. No. 597482
New Zealand Pat. No. 600702
New Zealand Pat. No. 608461
New Zealand Pat. No. 614472
New Zealand Pat. No. 625575
New Zealand Pat. No. 702992
New Zealand Pat. No. 732515
New Zealand Pat. No. 739881
New Zealand Pat. No. 779783
Spanish Pat. No. 1768490
Spanish Pat. No. 3347084
Swedish Pat. No. 1768490
U.K. Pat. No. 1768490
U.K. Pat. No. 3347084

Organ Care System (OCS) Liver

U.S. Pat. No. 6,046,046
U.S. Pat. No. 6,100,082
U.S. Pat. No. 8,585,380
U.S. Pat. No. 9,055,740
U.S. Pat. No. 10,076,112
U.S. Pat. No. 11,154,050
U.S. Pat. No. 11,903,381
U.S. Pat. No. 11,944,088
Australian Pat. No. 728233
Australian Pat. No. 2008260409
Australian Pat. No. 2013216566
Australian Pat. No. 2014256394
Australian Pat. No. 2015271799
Australian Pat. No. 2019206070
Australian Pat. No. 2020270499
Austrian Pat. No. 3151663
Belgian Pat. No. 3151663
Canadian Pat. No. 2950759
Chinese Pat. No. ZL201310556156.3
Chinese Pat. No. ZL201580039132.8
Chinese Pat. No. ZL202110528345.4
Czech Pat. No. 3151663
Danish Pat. No. 3151663

European Pat. No. 3151663
French Pat. No. 3151663
German Pat. No. 3151663
Hong Kong Pat. No. HK1236750
Hong Kong Pat. No. HK40057540
Irish Pat. No. 3151663
Israeli Pat. No. 249277
Israeli Pat. No. 273266
Israeli Pat. No. 296525
Israeli Pat. No. 303658
Israeli Pat. No. 285965
Italian Pat. No. 3151663
Japanese Pat. No. 5746534
Japanese Pat. No. 5889861
Japanese Pat. No. 7530239
Netherlands Pat. No. 3151663
New Zealand Pat. No. 600702
New Zealand Pat. No. 726895
New Zealand Pat. No. 765006
Spanish Pat. No. 3151663
Swedish Pat. No. 3151663
U.K. Pat. No. 3151663

OCS Lung Solution Set

U.S. Pat. No. 6,953,655
U.S. Pat. No. 9,078,428
New Zealand Pat. No. 616699
Austrian Pat. No. 1017274
Belgian Pat. No. 1017274
Danish Pat. No. 1017274
European Pat. No. 1017274
Finnish Pat. No. 1017274
French Pat. No. 1017274
German Pat. No. 1017274
Irish Pat. No. 1017274
Italian Pat. No. 1017274

Luxembourg Pat. No. 1017274
Monaco Pat. No. 1017274
Netherlands Pat. No. 1017274
Portuguese Pat. No. 1017274
Spanish Pat. No. 1017274
Swedish Pat. No. 1017274
Swiss Pat. No. 1017274
U.K. Pat. No. 1017274
Canadian Pat. No. 2304598
Japanese Pat. No. 5923551
Japanese Pat. No. 5923552

OCS Heart Solution Set

U.S. Pat. No. 6,953,655
U.S. Pat. No. 9,078,428
Austrian Pat. No. 1017274
Belgian Pat. No. 1017274
Danish Pat. No. 1017274
European Pat. No. 1017274
Finnish Pat. No. 1017274
French Pat. No. 1017274
German Pat. No. 1017274
Irish Pat. No. 1017274
Italian Pat. No. 1017274

Luxembourg Pat. No. 1017274
Monaco Pat. No. 1017274
Netherlands Pat. No. 1017274
Portuguese Pat. No. 1017274
Spanish Pat. No. 1017274
Swedish Pat. No. 1017274
Swiss Pat. No. 1017274
U.K. Pat. No. 1017274
Canadian Pat. No. 2304598
Japanese Pat. No. 5923551
Japanese Pat. No. 5923552

OCS Liver Sterile Bile Salts Set

U.S. Pat. No. 6,953,655
U.S. Pat. No. 9,078,428
Austrian Pat. No. 1017274
Belgian Pat. No. 1017274
Danish Pat. No. 1017274
European Pat. No. 1017274
Finnish Pat. No. 1017274
French Pat. No. 1017274
German Pat. No. 1017274
Irish Pat. No. 1017274
Italian Pat. No. 1017274

Luxembourg Pat. No. 1017274
Monaco Pat. No. 1017274
Netherlands Pat. No. 1017274
Portuguese Pat. No. 1017274
Spanish Pat. No. 1017274
Swedish Pat. No. 1017274
Swiss Pat. No. 1017274
U.K. Pat. No. 1017274
Canadian Pat. No. 2304598
Japanese Pat. No. 5923551
Japanese Pat. No. 5923552

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