A Medical Device Daily

EDAP TMS (Lyon, France), a developer of minimally-invasive devices for the treatment of urological diseases, released supplemental details on the conclusion of a distribution agreement with HealthTronics (Austin, Texas).

EDAP TMS said that it has entered into an agreement with HealthTronics Surgical Services to terminate its 2004 distribution agreement with HealthTronics originally entered into in 2004 to pursue FDA approval of EDAP's Ablatherm-HIFU device for use in the U.S.

In accordance with the termination, on April 4, HealthTronics exercised 200,000 warrants granted under the distribution agreement to acquire an equal number of EDAP's shares, paying an aggregate exercise price of $300,000. The 600,000 remaining warrants granted under the distribution agreement were cancelled.

EDAP also agreed to file a registration statement under the Securities Act of 1933 to enable HealthTronics to resell its shares in transactions that are registered under the Securities Act.

HealthTronics agreed to pay EDAP $600,000 after the resale registration statement has been effective for 60 days. EDAP may also receive additional cash compensation based on a formula related to the price at which HealthTronics resells the EDAP's shares in the future.

HealthTronics agreed to transfer to EDAP one Ablatherm device and six lithotripters previously acquired by HealthTronics, and to return two Ablatherm devices already owned by EDAP. The transfer of these devices is part of the overall termination transaction and their value is included in the estimated transaction value.

The EDAP parties and HealthTronics parties released each other from liabilities arising under the terminated agreement, and agreed to indemnify each other for breaches of the termination agreement and certain liabilities arising from any claims related to the use of the Ablatherm-HIFU device and the conduct of the clinical study evaluating the Ablatherm-HIFU device.

In other agreements:

• Transgenomic (Omaha, Nebraska) said it will provide Spectrumedix (State College, Pennsylvania) instrument service and consumables support in the U.S. and other areas as well as continue the offering to European customers of Spectrumedix.

Transgenomic has been the exclusive Spectrumedix systems European distributor since 2003, and Spectrumedix customers were affected by the SpectruMedix decision to discontinue operations after March 9.

Spectrumedix systems are high-throughput capillary electrophoresis (CE) instruments designed for various applications including comparative genome scanning, SNP genotyping, heterozygote identification, fragment sizing, PCR quality testing, and custom assay development.

Transgenomic also reported acquiring certain assets from the SpectruMedix court-appointed receiver and a license from the gel patent holder necessary to manufacture consumables for Spectrumedix systems.

Financial terms of these transactions were not disclosed.

Craif Tuttle, president/CEO of Transgenomics, said, "We are pleased to announce this series of transactions which clarifies this situation for Transgenomic and its European customers subject to the limitations of no longer being supported by Spectrumedix itself. Additionally, we intend to service and support other Spectrumedix customers as well, subject again to the same limitations."

• Accuray (Sunnyvale, California), focused on the field of radiosurgery, signed a co-marketing and distribution agreement with Siemens Medical Solutions USA (Malvern, Pennsylvania), enabling Accuray to integrate its CyberKnife Robotic Radiosurgery System and RoboCouch Patient Positioning System with a Siemens SOMATOM computed tomography (CT) scanner with a sliding gantry configuration. The combination enhances visibility of internal structures at the time of treatment, according to the companies.

The companies said that the clinical benefits of the in-room diagnostic CT system are realized "mainly in the treatment of tumors that move with respiration, such as lung, liver and pancreas, as well as prostate tumors, which are impacted by bowel and bladder function."

Unlike cone beam CT, diagnostic CT provides higher resolution imaging and allows for differentiation of soft tissue structures.