The perceived need for an Israeli innovative cell therapy that could treat critical limb ischemia (CLI) in the US is expected to be worth $2 billion by 2023.Last week, the Haifa-based regenerative-medicine company Pluristem Therapeutics announced the results of a research study that found CLI “has a significantly unmet need indication and constitutes a significant burden on the US healthcare system.”CLI is a serious condition in which there is inadequate blood flow and oxygen to a specific part of the body. This could be the hands, feet or other extremities. According to a statement released by Pluristem, the report included data from published literature as well as from direct interviews with dozens of physicians, who are key opinion leaders (KOL) in how to treat CLI, and with payers covering millions of lives.The report concerned Pluristem’s PLX-PAD regenerative cell therapy, which is in its clinical trial phase.“Pluristem believes that the in-depth report reflects a favorable market for PLX-PAD, which is currently in a global Phase III study with clinical sites in the US, Europe and Israel,” it said.The report, conducted by the Marwood Group, also suggested that “the addressable market for PLX-PAD for Rutherford V CLI patients,” in which patients suffer tissue loss or damage from the lack of blood flow and who are unsuitable “for revascularization, is expected to reach $2 b. by 2023.” Revascularization is defined as the restoration of blood and oxygen, otherwise known as perfusion, to a body part or organ that has suffered ischemia.Ayala Michael, Pluristem’s marketing communications manager, told The Jerusalem Post last Thursday the market access study “validates the fact CLI is a significant unmet need indication in the US, a medical condition with no cure or solution other than revascular surgical procedure, which not all patients are suitable for.”Other than providing a potential solution for the disease, an important aspect of the report “addresses the disease’s significant burden on the US healthcare system and the fact that payers well recognize the current cost of potential amputation and of treating CLI,” she said.Pluristem said about 35% of CLI patients today are unsuitable for revascularization surgery, “according to KOLs and market researchers in this field, and face high rates of death and amputation, which carries high medical and personal costs.”The average cost for a major amputation in the US is estimated at $47,000, with estimated ongoing annual costs for amputees at $75,000 and lifetime cost of $500,000 to $800,000.“So many patients [suffering from CLI] see amputation as a cost benchmark for a new treatment like PLX-PAD, meaning that they are willing to pay for the product,” Michael told the Post.The report also highlighted that vascular surgeons, who typically treat CLI, expressed interest in using PLX-PAD, which would be provided in an outpatient setting.“[This] potentially reduces the need for hospitalization,” she said. PLX-PAD is being evaluated in Phase III clinical studies both in CLI and in muscle regeneration following hip fracture to determine when it will be available in hospitals commercially, Michael said.“Recently, Pluristem has announced achieving 75% enrollment in this study,” she said. “After a one-year follow-up period, all data will be received and, if positive, will potentially lead to product approval by the regulators, hopefully during 2021.”Pluristem president and CEO Yaky Yanay said: “Based on this thorough market report, it is clear to us that CLI patients, and especially those unsuitable for revascularization that are suffering from a very poor quality of life and carry a heavy burden on the healthcare system, require better medical solutions.”Pluristem believes this market report highlights “payers’ and physicians’ interest in PLX-PAD as an alternative method of care for CLI patients,” he said. “We also believe that this market report validates our understanding regarding the potential substantial market for our PLX-PAD product in the US and the importance of implementing novel regenerative medicine in CLI to control increased healthcare spending.”“Pluristem is committed to finding a solution for CLI and believes that our Phase III study will show promise in preventing amputation and help improve the lives of millions of CLI patients,” Yanay said.