UroMed launching Impress Softpatch female incontinence device in early 1998, company tells analysts.

UROMED LAUNCHING IMPRESS SOFTPATCH FEMALE URINARY INCONTINENCE DEVICE in the U.S. the first half of 1998 following scale up of manufacturing at the firm's Needham, Massachusetts facility. The single-use, soft foam patch device, which gained 510(k) clearance in mid-1996, is applied using a gel-adhesive strip to the labia of a patient to prevent urinary leakage.

The company expects to receive in the next four to six weeks automated equipment needed to manufacture Impress. "When that gets up and running, it's going to have about an 80 mil. unit per year capacity," company President and CEO John Simon said at an Oct. 30 session of the Dain Bosworth investment conference in Boston.

UroMed's 30-40 person direct sales force will target the urology and general practitioner markets for sales of the prescription device. The company also is discussing possible co-promotion agreements with other firms "to maximize Impress penetration" in the U.S., Simon said. The device will be sold in packs of 24 and 48 at a tentative list price of 90 [cents] per unit. UroMed is discussing Medicare coverage with the Health Care Financing Administration and expects that private insurers will agree to pay for the device.

Addressing the reimbursement issue, Simon told investors that to date, UroMed has "about 20 mil. covered lives under agreement now in terms of insurance plans that are reimbursing for our complete non-surgical continuum," which includes several products used to treat urinary incontinence. He added that "by the time we launch Impress by the first half of next year, we hope that that's somewhere between 50 and 100 mil. covered lives." Significant insurance coverage "is key to the marketplace," Simon remarked.

The company cites lack of reimbursement as one reason for lower than anticipated sales of its Reliance urinary control insert when the product was launched in early 1997. UroMed posted revenues of $42,000 for the third quarter (ended Sept. 30), compared to $800,000 in the year-ago period, and the firm reported a net loss of $8.6 mil. for the quarter, compared to a loss of $5.4 mil. during the same period in 1996. The company also pointed to "minimal sales" of its Introl bladder neck support prosthesis in announcing third quarter results. The company expects modest revenues for the next several quarters until its new products hit the market.

UroMed also announced plans to launch its Beacon Technology System, a minimally invasive incontinence surgical line, in the first six months of 1998. A price has not yet been set for the Beacon system, for which UroMed plans to handle distribution through its own direct sales force.

UroMed's product pipeline includes the BreastCheck breast self-exam device, which is expected to enter clinical trials in the first quarter of 1998. The trial, which is expected to last two to four months, will enroll 1,000 patients at 10 sites in the U.S., the company says.

UroMed is still in discussion with FDA as to whether its marketing submission will support an indication for use of the device by physicians or patients. The device is intended for use as an aid to the hand in improving breast examinations. The upcoming study is designed to support this indication for use both by the physician and by the patient, the company says. Investigators in the study will compare data on women performing a self-exam with and without the BreastCheck device to physical exam by a breast cancer specialist.

The firm plans to market the BreastCheck to women for use during monthly self-examinations. The device consists of a reusable hand-held instrument and a disposable kit, which includes a sensor cap and lubricant.

The hand-held component consists of a one-inch sensor with resistors that sense the force of the breast pushing back as the sensor is glided over the breast. Because a lump in the breast reacts with a different pressure than does soft tissue, the device can detect the presence of a lump. The BreastCheck emits an audible signal to alert the user to the presence of a lump. Following discovery, the user is recommended to perform a self-exam and have an exam conducted by a physician.

UroMed expects to submit in the second or third quarter of 1998 a premarket approval application for the device, which has been granted expedited review status by FDA. An investigational device exemption was not needed for the product because it is considered a non-significant risk device, according to UroMed. If FDA reform legislation is enacted, UroMed may want to consider use of a provision allowing novel, low-risk devices to be placed in Class II instead of defaulting to Class III PMA status. The provision was included in response to FDA's attempt to require a PMA for Inventive Product's SensorPad breast self-exam device.

The yearly cost of the BreastCheck disposable kits will be about $20-$50, UroMed says, while the reusable device will cost between $100 and $400. A version of the device for use by physicians, the BreastExam, is planned as well. The device will cost between $500 and $1,000 because it will have slight modifications from the patient version, according to UroMed. For example, the physician-use BreastExam will employ a visual signal instead of an audible tone to signify the presence of a lump. In addition, the physician device will provide different battery options.

A 510(k) for the firm's CaverMap surgical aid for use in sparing vital nerves during prostate cancer surgery is pending at FDA, UroMed reports. The company has provided supplemental information as a result of questions posed by FDA, and the firm expects the agency's response in the near future.

The CaverMap is comprised of a probe handle, used with a disposable probe tip, connected to an electronic control box by a cable, and a tumescence monitor. During prostate surgery, the probe is placed into the surgical field where it provides low levels of electrical stimulation. If stimulation occurs on or near a nerve, the tumescence monitor, which encircles the penis, records changes in the penis and displays them on the control box. The device thus informs physicians of the location of nerves and allows incisions to be made around them, helping to prevent impotence.