TherMatrx is hoping that the design of its TMx-2000 transurethral microwave thermotherapy system to treat benign prostatic hyperplasia - specifically, the absence of a cooling mechanism - will give it an edge over comparable devices on the market.

Indicated for treatment of BPH in men with urethral length of 30 mm and total prosthetic volume of 30-100 cc, the TMx-2000 is being launched immediately following FDA approval June 29, the firm said. TherMatrx will employ a direct sales force to target urologists.

Designed for use in a doctor's office, the device yields fewer patient side effects, such as pain, while achieving outcomes equivalent to those of high-energy, cooled devices on the market, TherMatrx claims.

The Chicago firm's TMx-2000 will compete with Urologix' Targis and Prostatron, both of which utilize proprietary cooled thermotherapy technology.

Urologix licenses patents from TherMatrx for the Targis and Prostatron, but the Minneapolis-based Urologix, holds the patents on the cooled thermotherapy technology, and maintains that the system is advantageous.

The cooling factor increases microwave penetration and patient comfort, contributes to shorter recovery times, and provides more effective and durable outcomes, Urologix says.

TherMatrx disagrees, citing clinical data suggesting lower incidence of side effects and greater patient tolerance with the TMx-2000. The firm touts its lower-energy treatment requirements as equally safe, if not safer, than the high-energy, cooled systems.

"The TMx-2000 is designed so that cooling is not required," TherMatrx notes in a product brochure. "This means that the therapy can be run at low, safe wattage levels of 5-20 W."

The lack of cooling properties in the TMx-2000 also facilitates the tracking of tissue temperature, according to TherMatrx. The TMx-2000 features a proprietary closed-loop temperature system with two catheters and one rectal sensor. The product also has a patient control button allowing patients to modify treatment ramp-up.

To support its claim of a lack of serious side effects associated with the TMx-2000, TherMatrx points to the results from a 200-patient, multicenter, Phase III IDE clinical study. "Side effects of treatment were few and minor," TherMatrx notes in its brochure, citing a FDA public health notice in listing adverse events for competing devices.

Last fall, FDA issued a public health notification communicating several infrequent but serious adverse events that had occurred with the Prostatron and Targis devices (¹ Also see "BPH Microwave Thermotherapy Injuries Serious But Infrequent - FDA Notice" - Medtech Insight, 16 October, 2000.).

Among injuries were fistula formation and tissue damage to the penis or urethra. Possible underlying causes mentioned in the notice include: incorrect placement or undetected migration of either the treatment catheter or rectal temperature sensors; failure to comply with labeling; and over-sedation resulting in a lack of communication of pain by the patient.

"We believe TherMatrx has addressed the problems associated with the current microwave thermotherapy systems and is nicely positioned to be a dominant player in this market," BSD Medical President Hyrum Mead said in a July 3 company release. In 1997, Salt Lake City-based BSD teamed with Oracle Strategic Partners to form TherMatrx, a 30/70 joint venture.

FDA approved the Targis in 1997, and the Prostatron, which Urologix later acquired from Edap Technomed, received approval in 1996.

TherMatrx' ability to grab a significant share of the TUMT market will likely depend on long-term data indicating whether the device will maintain low adverse event rates and comparable outcomes.

TherMatrx dismisses concerns that design differences will exclude the device from existing reimbursement codes. The TMx-2000 will be reimbursable under the transurethral microwave thermotherapy CPT code 53850, TherMatrx says.

BPH Thermotherapy Device Competition Heats Up With TherMatrx Entry

More from Archive

More from Medtech Insight