PEAK Surgical Announces Positive Results From Preclinical Study Of PEAK PlasmaBlade(TM) For Obstetric And Gynecologic Surgery

PEAK Surgical, Inc., a medical
device company that is developing new tissue dissection systems based on a
proprietary technology, released results from a preclinical study
demonstrating that its PEAK PlasmaBlade(TM) cut freshly excised human
abdominal tissue with little thermal tissue injury compared with
traditional electrosurgery. The PEAK PlasmaBlade is a low-temperature
tissue dissection tool that uses pulsed plasma energy to create surgical
incisions and control bleeding.



The data also showed improved surgical incision wound healing in an in
vivo porcine model compared to traditional electrosurgery. The results were
presented in a poster session at the American College of Obstetricians and
Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans by lead
investigator Dr. Paul Blumenthal, M.P.H., professor in the Department of
Obstetrics and Gynecology at Stanford University School of Medicine.



"The findings of this comparative preclinical study of tissue cutting
and healing are encouraging because they demonstrated that cuts made with
the PEAK PlasmaBlade produced minimal collateral damage compared with cuts
made with currently available electrosurgical instruments," Dr. Blumenthal
said. "This is important because collateral tissue damage may impede wound
healing, obscure histological analysis, and lead to scarring and infection
in surgical patients. New surgical cutting tools that use less heat but
offer precise soft-tissue cutting and coagulation with minimal thermal
injury could change the way we operate."



The PEAK Surgery System is not yet available in the United States. The
company has filed a 510(k) pre-market notification with the U.S. Food and
Drug Administration to market the system in the United States.



Study Design



In the study, freshly excised human abdominal tissue was cut using the
PEAK PlasmaBlade, an uncoated traditional electrosurgery scalpel, a
teflon-coated traditional electrosurgery scalpel and a fine wire and
ceramic electrosurgery scalpel. Histology samples were immediately
harvested to evaluate acute thermal tissue injury.



Also as part of the study, full-thickness skin incisions were made on
porcine skin using a traditional electrosurgery device, the PEAK
PlasmaBlade and a standard scalpel blade. Incisions were made at days 0,
21, 28, 35 and 42, and bleeding was evaluated for 60 seconds post-incision.
The wounds were then sutured to allow for healing, and digital photos of
the wounds were taken every seven days to evaluate scarring based on a
visual analog scale. Histological examination was conducted to evaluate
healing and inflammatory response.



Study Results



Histological evaluation of the ex vivo human skin showed that the PEAK
PlasmaBlade cuts produced minimal collateral damage compared to cuts made
with the other electrosurgery instruments.
















In the porcine skin cuts, bleeding for 60 seconds following incision
was reduced by 60 percent in the wounds made by the PEAK PlasmaBlade
compared with those made by the standard scalpel (p=0.0001). Wound sections
showed a 75 percent reduction in acute thermal damage with the PEAK
PlasmaBlade compared with the traditional electrosurgery scalpel (p