FDA approves Harvest's BMAC System IDE trial to treat non-reconstructable Critical Limb Ischemia

Harvest Technologies Corp. (www.harvesttech.com) announced today that the FDA has approved the company sponsored 210-patient IDE clinical trial to be conducted at twenty-five sites in the U.S. using the company's proprietary Bone Marrow Aspiration Concentrate (BMAC) System to treat patients with non-reconstructable Critical Limb Ischemia (CLI). Mark D. Iafrati, M.D. Chief of Vascular Surgery at Tufts Medical Center in Boston is the trial's Principal Investigator. "The patients enrolled in this study are at high risk for limb loss and death and have no usual treatment options with bypass or catheter-based techniques. Although the 48 patient randomized, double blinded, pilot trial (RCT) was aimed at determining the safety of this approach and not powered for efficacy, as will be the pivotal trial, the data suggested that there are benefits in terms of limb salvage, pain relief, and quality of life.  If the pivotal study confirms these findings this would be a dramatic affirmation of the role of autologous (patient's own bone marrow stem cells) cellular therapy in critical limb ischemia. BMAC therapy is so much faster, less invasive, and less expensive than traditional vascular interventions, that if proven efficacious will certainly result in an immediate change in the standard of care for patients with end stage peripheral vascular disease."  The pivotal study will enroll 210 patients with data analysis after the last subject has completed 6 months of follow-up. The company anticipates that enrollment should begin early in the second quarter of this year.

Critical limb ischemia (pain at rest with or without tissue damage) is a persistent and relentless problem, which is increasing due to the aging of our population as well as the growth of diabetes mellitus in the general population. CLI has an annual incidence of 500-1000 cases per million.  CLI severely impairs patients' functional status and quality of life, and is associated with an increased cardiovascular mortality and morbidity. The prognosis of CLI is poor. Even when patients are candidates for current revascularization therapies such as angioplasty or bypass surgery, these therapies are commonly accompanied by significant morbidity and mortality risk. The outcomes are uniformly poor in patients who are not candidates for conventional therapies, as was the case in the patients enrolled in this clinical trial. These patients are afflicted with intractable pain and a very high risk of limb loss and/or death. To put this into perspective, a recent consensus document developed by over 16 vascular societies stated: "Observational studies of patients with CLI who are not candidates for revascularization suggest that a year after the onset of CLI, only about half the patients will be alive without a major amputation, although some of these may still have rest pain, gangrene or ulcers. Approximately 25% will have died and 25% will have required a major amputation. Their prognosis is in many ways similar to that of some malignancies. "

Although autologous cell therapy has been studied as an innovative treatment option for CLI, previously published non-RCTs did not use a rapid, point of care method for processing the cells therefore making widespread adoption of the therapy problematic. The Harvest pilot trial utilized the BMAC system, which processes the cells in 15 minutes in the operating room. A unique feature of both the upcoming pivotal trial and the preceding pilot trial was that it compared the relative effectiveness of the BMAC to a control injection of a placebo and detailed the safety profile of the device and the technique. Neither the subjects nor the investigators know which material was being injected.  

"We are very privileged to work with the leading Medical Centers across the US helping document what may be a significant treatment option for this extremely sick, no treatment option, patient population. The results generated from the Company's 48 patient FDA Safety and Pilot study and the results of the Company's additional BMAC studies in Europe and Asia, treating over 300 end-stage CLI patients, have all been extremely encouraging. The Harvest BMAC System is a simple to use 15 minute point-of-care process that has been used in the treatment of approximately 50,000 patients to date. The System concentrates the cellular composition of the patient's bone marrow, which contains the patient's own stem cells. The BMAC System's point-of-care approach, ease of use and its ability to deliver a cellular composition at an affordable price will be a major key in establishing this technique as a standard of care after the Company has received its FDA approval," stated Gary Tureski, President Harvest Technologies.