LANGHORNE, Pa., July 16, 2009 (GLOBE NEWSWIRE) -- Power Medical Interventions(r), Inc. (OTCBB:PMII), a leader in developing and commercializing Intelligent Surgical Instruments(tm), announced today that the company's proprietary i60 Mid Cut device was used at Palmetto General Hospital in Miami, Florida in a novel procedure known as laparoscopic vertical gastroplasty. This procedure is designed to combat obesity through a novel, less invasive surgical procedure which takes approximately 30 minutes to perform. The procedure was successful at reducing the size of the patient's stomach, without removing the stomach. This new minimally invasive procedure resulted in the patient losing 17 pounds in the first week following surgery. Jorge Sosa, M.D., chairman of the bariatric surgery department at Palmetto General Hospital, performed the procedure. He has successfully completed a total of seven laparoscopic vertical gastroplasties on morbidly obese patients, who are defined as having a Body Mass Index of 35 and over. Utilizing PMI's proprietary Mid Cut Reload and Intelligent 60 mm Endoscopic Linear Cutter, Dr. Sosa has had success with all seven patients, each of them having experienced significant weight loss in the weeks and months following the procedure.
In addition to weight loss, some of the seven patients also experienced the complete resolution of related health conditions including hyperlipidemia and sleep apnea, as well as significant improvement in type 2 diabetes. All seven procedures were completed safely.
"The obesity epidemic that is plaguing the United States has necessitated the development of new and effective ways to assist patients in combating this condition. While a variety of surgical procedures have been utilized to combat morbid obesity during recent years, each has significant limitations that present concerns for both patients and surgeons," said Dr. Sosa. "By leveraging the unique capabilities of PMI's instruments, we have been able to modify a safe and reliable traditional vertical gastric stapling approach -- known as the Magenstrasse and Mill procedure -- and perform a vertical (sleeve) gastroplasty using minimally invasive laparoscopic techniques. Based on the impressive results that we have seen to date with regard to weight loss, as well as various co-morbidities, we believe this procedure has the potential to become a mainstay in obesity surgery."
Enabled by PMI's computer-assisted, power-actuated surgical instruments and unique Mid Cut Reload, the laparoscopic vertical gastroplasties performed by Dr. Sosa are minimally invasive surgical procedures designed to create a narrow sleeve in the stomach using staples without removing the stomach. As a result of the operation, a significant portion of the stomach is partially sealed off but left in place, reducing the overall size of the functioning stomach and restricting its intake potential. Using PMI's instruments, Dr. Sosa was able to conduct the procedures laparoscopically, thus providing the patients significant benefits pertaining to pain and recovery time. Unlike some other obesity surgeries, the laparoscopic vertical gastroplasty is potentially reversible since no portion of the stomach is actually removed from the patient.
Based on Dr. Sosa's experiences to date, laparoscopic vertical gastroplasties performed using PMI's Mid Cut Reload have demonstrated key benefits as compared to other obesity surgeries. These include:
- Reduced incidence of "dumping syndrome," with sugar and
carbohydrate intolerance and malabsorption, as compared to
gastric bypass surgery. Dumping syndrome occurs when the
stomach's undigested contents are transported or "dumped"
into the small intestine too rapidly and is a common side
effect of gastric bypass surgery.
- Elimination of band maintenance requirements such as
adjustments and revisions, and improved weight loss as
compared to the Lap-Band procedures.
- Reduced operative time and potentially fewer surgical
complications as compared to sleeve gastrectomy, which
requires the removal of the majority of the stomach.
Avoiding removal of the stomach makes the vertical (sleeve)
gastroplasty less invasive, less painful, and potentially
a reversible procedure.
PMI expects that instruments the company has in late stage development will ultimately allow vertical gastroplasties to be performed using a NOTES(r) (Natural Orifice Translumenal Endoscopic Surgery) technique. NOTES is a new, minimally invasive surgical approach that involves passing surgical instruments through one of the body's natural orifices, such as the mouth in order to perform surgical procedures. Operating through the body's natural orifice offers the potential for minimizing, or potentially even eliminating, external incisions and scarring, thus potentially reducing recovery time, physical discomfort, and healthcare costs when compared to traditional and laparoscopic surgeries. PMI is a recognized leader in the emerging area of NOTES-based procedures, with the company's instruments having enabled physicians around the world to conduct first-of-their-kind surgeries.
"While our Intelligent Surgical Instruments are being used in groundbreaking surgical procedures across a wide variety of clinical indications, it is particularly gratifying to see the powerful impact our instruments are having with regard to morbid obesity surgery. Clearly, this is a segment of the healthcare industry that is in desperate need of effective therapeutic tools and we are pleased to have an opportunity to make a difference in this area," stated Michael Whitman, president and chief executive officer of PMI. "We are eager to continue to support Dr. Sosa's important efforts in the area of vertical gastroplasty, while also working with other surgeons across the country to perform similar procedures and deliver meaningful clinical results to their patients."
About PMI's Intelligent Surgical Instruments(tm)
PMI's Intelligent Surgical Instruments are computer-assisted, power-actuated endomechanical instruments that surgeons use for cutting and stapling in a variety of procedures in open surgery and minimally invasive surgery. The company believes that compared to conventional endomechanical devices, its Intelligent Surgical Instruments offer greater precision and consistency, superior compressive force, improved access to anatomical sites and enhanced ease of use.
About Power Medical Interventions, Inc.
Power Medical Interventions is the world's only provider of computer-assisted, power-actuated surgical cutting and stapling products. PMI's state-of-the-art wireless Intelligent Surgical Instruments are revolutionizing and expanding minimally invasive surgery applications and enabling novel surgical procedures to benefit surgeons, patients, hospitals and healthcare networks. To learn more about Power Medical Interventions, Inc. and its products, please visit www.pmi2.com.
Safe Harbor Statement
Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements relating to the future financial performance of the Company are subject to many factors including, but not limited to, the Company's ability to raise additional capital; the Company's ability to restructure its debt; the ability of the Company's products to achieve broad market acceptance; the possibility of incurring additional losses in the foreseeable future; the Company's inability to further identify, develop and achieve commercial success for new products and technologies; the Company's difficulty in increasing production to provide customers with adequate supply; the Company's inability to improve gross margins; loss of the Company's key suppliers; the Company's inability to manage continued growth; inability to remediate the Company's internal weakness over financial reporting and achieve and maintain effective internal control over financial reporting; failure in the Company's training efforts; the risk of product liability claims connected with the use of the Company's products; adverse effects or risks relating to the Company's sales in international markets; the Company's inability to comply with the covenants of its 7% Senior Convertible Secured Notes; the Company's inability to satisfy the requirements of the U.S. Food and Drug Administration and other regulatory agencies; loss of key personnel; lack of third party coverage and reimbursement for the Company's products; risk of loss of the Company's key manufacturing facility, and other risks detailed in the Company's Securities and Exchange Commission filings, including the Company's Report on Form 10-Q for the quarterly period ended March 31, 2009 and Annual Report on Form 10-K for the year ended December 31, 2008.
Such statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. When used in this press release the terms "anticipate," "believe," "estimate," "expect," "may," "objective," "plan," "possible," "potential," "project," "will" and similar expressions identify forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information or otherwise.