A Medical Device Daily

Integrated Surgical Systems (ISS; Sacramento, California), a developer of medical robotics and image-directed, robotic surgical applications, reported an agreement with Novatrix Biomedical (San Clemente, California), for Novatrix to purchase substantially all of ISS's assets.

The principal terms of the transaction were disclosed in a Current Report on Form 8-K filed with the Securities and Exchange Commission on Aug. 8.

ISS said it has reached a settlement with the majority of its creditors to repay most of its outstanding debt. ISS has notified the U.S. Securities and Exchange Commission that it intends to bring all of its quarterly and annual filings current from the date of its last filing of Dec. 31, 2004.

ISS said its main focus to reinitiate and complete multi-center U.S. clinical studies for the Robodoc surgical system. ISS has secured authorization from the FDA for an additional clinical site in the U.S. and has received permission to restart the clinical studies.

To expedite the studies, ISS is negotiating with an overseas hospital to conduct clinical studies following the U.S. protocol and said it has "secured the necessary infrastructure, recruited two of its previous officers, hired a limited number of former employees and appointed Michael Tomczak, a former chief financial officer of ISS, and Peter Mills as directors of the company. Dr. Ramesh Trivedi continues to serve as ISS CEO."

ISS has entered into a four-year lease to relocate its operations in Sacramento and expects to move into the new facility on or before Dec. 1.

ISS manufactures and services image-directed computer-controlled robotics products for use in orthopedic and neurosurgical procedures. Robodoc is a robotic system used for hip and knee replacement surgery.

In other dealmaking:

  • Ciphergen Biosystems (Fremont, California) reported receiving stockholder approval to sell its proteomics instrument business to Bio-Rad Laboratories (Hercules, California) for about $20 million in cash. In addition, Bio-Rad will make a $3 million equity investment in Ciphergen.

"With the approval of the sale of the instrument business, Ciphergen completes its transition into a specialty diagnostics company and is well-positioned to bring high-value molecular diagnostics to physicians and their patients," said Gail Page, president/CEO of Ciphergen.

Ciphergen said it expects to close the transaction on or before Nov. 1 and will have about 50 employees dedicated to introducing diagnostic tests in oncology/hematology, cardiology and women's health. The company's initial program is focused in ovarian cancer. It entered a three-year strategic alliance with Quest Diagnostics (Lyndhurst, New Jersey) in 2005 to develop proteomic diagnostic tests from its pipeline, including the first proteomics-based test for ovarian cancer.

"We anticipate that our first diagnostic test will be used as an adjunct to other diagnostic methods to help physicians in the differential diagnosis of a persistent pelvic mass," said Page. "[W]e are initiating a prospective clinical trial to support our submission to the FDA for clearance as an in vitro diagnostic test in the U.S. and to additional regulatory agencies in other countries."

Bio-Rad will manufacture the Surface Enhanced Laser Desorption/Ionization technology for proteomics that includes biomarker discovery and validation. Ciphergen will retain rights to the diagnostics market and will enter into an agreement to purchase instruments from Bio-Rad for the continued development of its diagnostics business.

Ciphergen has diagnostic programs in oncology, hematology, cardiology and women's health.

  • Empire Investment Holdings (Miami, Florida) reported that its affiliate, MSI SurgicalSolutions (Syosset, New York),has completed the acquisition of the off-site surgical reprocessing division of SSI Surgical Services (SSI; Orlando, Florida), a company that reprocesses reusable surgical instrumentation and supplies. Terms of the transaction were not disclosed.

SSI has been renamed MSI Surgical Solutions and will maintain its headquarters in Syosset. "Bringing back the MSI name was a key first step in our strategic growth plan," said David Alfonso, Empire's CEO and chairman, and will operate as a stand-alone entity.

MSI provides reprocessing for more than 35 hospitals and surgery centers in three states. SSI's services include endoscopy management, surgical instrument sterilization.

  • Plymouth Health (San Diego), a newly formed physician-owned company, said it will purchase Alvarado Hospital Medical Center (San Diego) from a subsidiary of Tenet Healthcare (Dallas). Financial terms of the deal were not disclosed.

Plymouth is a physician-owned company formed to acquire and operate Alvarado Hospital Medical Center. The company will continue operating Alvarado as an acute care facility and maintain its 24-hour emergency room services.

The sale or closure of Alvarado Hospital Medical Center was required by the San Diego U.S. Attorney's office and the Office of Inspector General in the U.S. Department of Health and Human Services as part of an agreement to end more than three years of prosecution of the hospital and its former CEO regarding physician relocation agreements. Tenet had said it would seek a buyer to continue operating the hospital as an acute care facility by the February 2007 deadline. Plymouth's purchase of Alvarado ensures the hospital's participation in state and federal healthcare reimbursement programs.