Sgarlato Labs, Inc. Introduces New Painfree Pump At the American Academy of Orthopaedic Surgeons Annual Meeting.

Business Editors, Health/Medical Writers

American Academy of Orthopaedic Surgeons

LOS GATOS, Calif.--(BW HealthWire)--Feb. 13, 2002

Only Patented, Spring-Operated, Post-Operative Pain Pump On the

Market Provides Improved Care With Less Pain and Risk to Patients

Sgarlato Labs, Inc., the leader in portable infusion pain management, today unveiled its revolutionary new PainFree pump(TM) at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Dallas (Booth No. 1919).

The PainFree pump is the newest generation of Sgarlato Labs' disposable, single-patient use, ambulatory drug delivery system designed to provide continuous, reliable infusion of a local anesthetic directly to the surgical wound site for one up to eight days. Studies have shown that the PainFree pump reduces the need for potent systemic narcotics; allows for quicker patient recovery and hospital release; promotes healing and earlier rehabilitation; and saves time and costs associated with surgeon follow-up and staff care after surgery. The new pump is used across a broad range of specialties including orthopedic, general surgery, ob-gyn, plastic surgery, podiatry and sports medicine.

According to Dr. Thomas E. Sgarlato, president and founder of Sgarlato Labs: "Sgarlato Labs has pioneered the pain management market since 1996, when we first introduced and since sold more than 100,000 of the PainFree pump's predecessor -- the Pain Control Infusion Pump (PCIP). Now, we're pleased to expand our product line with several new enhancements found in the PainFree pump, based on physician and patient feedback, clinical research studies and our own ongoing R&D efforts."

PainFree pump Innovations: Increased Reliability, Accuracy and Versatility

Benefits of the PainFree pump to physicians include:

-- Patented, spring-loaded design -- provides continuous, regulated flow rate
accuracy, unlike balloon or vacuum pumps. The PainFree pump is not gravity,
temperature or pressure dependent. B-Braun manufactures the pump for Sgarlato
Labs.

-- Easy-to-fill, all-in-one sterile packaging -- the closed system is
functionally latex-free to minimize allergic reactions. In over 100,000
Sgarlato pumps sold, the infection rate is currently less than one percent.

-- 15 customizable set-up options -- facilitates versatile, easy insertion for
intra-articular, sub-cutaneous or sub-fascia applications. The physician
chooses the medication (e.g., Bupivacaine HCl, Lidocaine HCl, or Ropivacaine
HCl), flow rate and time of therapy, selecting between 100ml or 200ml pumps;
.5ml, 1ml, 2ml or 4ml/hour flow regulators; and multiple catheter choices (20
gauge 3 port and 20 gauge 5 port) and multi-site "Y" connector.

-- Full compliance with JCAHO (Joint Commission on Accreditation of Healthcare
Organizations) Pain Management standards.

Clinical Research Proves Pump's Merit

According to a prospective, randomized trial involving 62 patients undergoing shoulder surgery, there was a statistically significant difference in pain relief and the amount of oral narcotics taken between groups of 31 patients receiving Bupivacaine versus 31 patients receiving saline infusions, both via the Sgarlato pump at a constant rate of 2ml/hour. The study, which appeared in Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol. 16, No. 4 (May-June), 2000, showed that the pump was a highly effective means of decreasing post-operative pain from days one through five.

"We're very encouraged by these findings, as the trend toward outpatient surgery, shorter hospital stays and the overall financial pressure on the healthcare system has prompted the medical community to seek more efficient ways to treat patients' pain. Sgarlato Labs' pain control pump lets patients heal without considerable discomfort which might otherwise inhibit recovery, lengthen rehabilitation and result in increased costs," said the lead investigator and study author, Felix H. Savoie, M.D. from the Mississippi Sports Medicine and Orthopedics Center, Jackson, Miss.

A second study, which has not yet been published, of 134 patients conducted by Granger Orthopedics and Sports Medicine (West Valley City, Utah) found the pump to be the safest and most efficient ambulatory delivery system during the acute pain period (48 hours) following arthroscopic, arthroscopically assisted and arthroplasty procedures of the knee. A cost-benefit analysis was also conducted, demonstrating significant health care costs savings through the use of the pump -- ranging from $1,200 to $5,200 -- due to reduction of patient controlled anesthesia, intra-muscular injections or oral analgesic medications.

Patients Benefit from Portable, Non-Invasive Design

The PainFree pump is portable, lightweight and easy for patients to wear, which lends itself to a wide spectrum of surgical procedures, including joint replacements (e.g., shoulder, hip); arthroscopy of the knee; hernia repair; hysterectomy; Cesarean section; mastectomy; breast augmentation; and surgery involving the hand and feet, among others. According to Susan Crocker, whose son used the pump following shoulder surgery, "Because he (Michael) did not have to use any narcotics and was in no pain, he was able to resume his routine the very next day after surgery. He felt so good that he progressed more quickly than the therapist anticipated. Because the pump managed his pain so well, Michael was able to do the exercises comfortably. If he had been in pain, I guarantee you he would have not have done the exercises as faithfully and would not have progressed as rapidly. I'll use his words, 'Mom, this is amazing.'"

Immediate Availability, Competitive Cost

The PainFree pump is available today through Sgarlato Labs' extensive network of independent distributors and sales force of over 300 representatives nationwide and internationally.

About Sgarlato Labs, Inc.

Founded in 1986 by Dr. Thomas E. Sgarlato, Sgarlato Labs is a surgeon-based company that invents, designs, manufactures and markets medical devices and innovations. Having pioneered the pain pump market since the introduction of the Pain Control Infusion Pump (PCIP) in 1996, Sgarlato Labs has redesigned its newest offering -- the PainFree pump(TM) -- as the only patented, spring-operated, post-operative pain management solution on the market. The company provides clinical, technical, in-service training, sales, marketing and insurance billing support from its Los Gatos, Calif.-based headquarters. For more information, the name of a local distributor or a copy of specific research, call 800/421-5303 or visit www.sgarlatolabs.com.

For photo of the PainFree pump, please contact Tricia Spellman, [e-mail]; 773/832-4074.