Harvest Technologies Announces Completion of Patient Enrollment in its Randomized, Controlled, Double Blind Multicenter IDE Non-Reconstructable Critical Limb Ischemia Trial

Harvest Technologies Announces Completion of Patient Enrollment in its
Randomized, Controlled, Double Blind Multicenter IDE Non-Reconstructable
Critical Limb Ischemia Trial
The first completed FDA/IDE trial using autologous adult stem cells
concentrated at point of care will be unblinded in 90 days

PLYMOUTH, Mass., Nov. 9 /PRNewswire/ -- Harvest Technologies Corp.
(www.harvesttech.com) announced today that the company sponsored 48-patient
IDE clinical trial conducted at seven sites in the U.S. and one site in India
using the company's Bone Marrow Aspiration Concentrate (BMAC) System to treat
patients with non-reconstructable Critical Limb Ischemia (CLI) has completed
enrollment. Mark D. Iafrati, M.D. Chief of Vascular Surgery at Tufts Medical
Center in Boston, directed the study. "This study was unique in the high
quality of the clinical investigators with each site being a center of
excellence. Thus these patients deemed to have no conventional reconstruction
possibility had truly exhausted current options. The BMAC procedure is easier
to perform, quicker, less expensive, and less traumatic to our patients than
most current treatments. If the results of this feasibility study demonstrate
tangible benefits, this could herald a tremendous advance in how we treat
patients with peripheral vascular disease." The study design calls for
preliminary data analysis after the last subject has completed the 12-week
follow-up visit. The company anticipates that these results should be
available by the end of February.

Critical limb ischemia is a persistent and relentless disease, which severely
impairs patients' functional status and quality of life, and is associated
with an increased cardiovascular mortality and morbidity. The prognosis of
critical limb ischemia 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. When patients are not candidates for conventional therapies as was the
case in the patients enrolled in this clinical trial, the outcomes are
uniformly poor. These patients are afflicted with intractable pain and a very
high risk of limb loss and/or death.

Autologous cell therapy has been studied as an innovative treatment option for
CLI, however; previously published studies did not use a rapid, point of care
method for processing the cells therefore making widespread adoption of the
therapy problematic. The Harvest trial utilized the BMAC system, which
processes the cells in 15 minutes in the operating room. A unique feature of
the trial was that it compared the relative effectiveness of the BMAC to a
control injection of a placebo. Neither the trial subjects nor the
investigators know which material was being injected. Thirty-two of the
subjects received the BMAC composition by injection and sixteen received the
placebo injection.

In July Harvest announced the completion of enrollment in another trial
treating sixty subjects in India suffering from a form of critical limb
ischemia referred to as Thromboangitis Obliterans. The 12-week follow up
results showed an amputation rate of only 10% and statistically significant
improvement in reduction of pain, in perfusion measures, and in quality of
life.

"We are particularly pleased that this study is now fully enrolled and by the
very promising results shown with the Indian data analysis," said Gary D.
Tureski, President of Harvest Technologies. "When combined with our other
studies in Germany and the Czech Republic, this study should provide one more
step in demonstrating the potential for Harvest's BMAC System to be an
effective treatment for Chronic Limb Ischemia regardless of the underlying
cause."

Harvest Technologies is a privately held company based in Plymouth, Mass.

Contact:
P. Kevin Benoit; VP / General Manager Strategic Business Development
- 508-732-7500

SOURCE Harvest Technologies Corp.

P. Kevin Benoit; VP - General Manager Strategic Business Development of
Harvest Technologies Corp., +1-508-732-7500