Somanetics

Somanetics was a United States medical-device company founded in 1982 by Gary Lewis to commercialize optical monitoring technology for measuring oxygenation in the brain and peripheral tissues. Its principal technology was marketed under the INVOS name, an abbreviation for In Vivo Optical Spectroscopy. The systems used near-infrared spectroscopy to provide clinicians with information about regional tissue oxygen saturation during surgical and critical-care procedures. Lewis initially raised $150,000 from friends and family before obtaining additional venture financing. Somanetics later became a publicly traded company, completing an initial public offering in March 1991 and trading on NASDAQ under the symbol SMTS. The company’s growth centered on regulatory approvals and successive generations of the INVOS monitoring platform. The INVOS 3100 entered marketing in 1993 after FDA clearance, although the FDA revoked that marketing authorization later the same year because of concerns about clinical-trial information submitted with the 510(k) application. Somanetics subsequently obtained approval for the INVOS 3100A in 1996 and the INVOS 5100 in 2000. In 2006, the FDA authorized an expanded indication allowing INVOS monitoring beyond the cranium to additional body sites. The company broadened its portfolio in 2008 by acquiring ICU Data Systems, a Gainesville, Florida company whose Vital Sync technology was designed to collect and integrate information from bedside medical devices, including ventilators and infusion pumps. Somanetics also received FDA approval for the INVOS 5100C that year. In 2009, the INVOS system was reported to be in use at approximately 700 hospitals in the United States and 1,200 hospitals internationally, illustrating the platform’s reach in perioperative and hospital monitoring. In May 2010, Somanetics received FDA approval for expanded Vital Sync functionality, including compatibility with additional medical devices, display of derived parameters, and configurable alerts when measurements crossed specified thresholds. Later in 2010, Covidien agreed to acquire Somanetics for $250 million. The transaction ended Somanetics’ independent corporate life, and the company announced the closure of its Michigan and Florida operations in connection with the acquisition. When Medtronic acquired Covidien in 2015, the Somanetics assets and the INVOS product franchise became part of Medtronic’s portfolio. Medtronic continues to market INVOS monitors and sensors, so the Somanetics corporate identity has largely been superseded while its principal technology remains commercially active under the INVOS brand.

Somanetics began in 1982 when Gary Lewis founded the company to commercialize technology capable of detecting oxygenation levels in the cranium, arms, and legs. The company’s initial financing included $150,000 raised from friends and family, followed by venture-capital funding. Its core technology was developed into the INVOS product family, with the name referring to In Vivo Optical Spectroscopy. The platform used optical measurements to estimate regional tissue oxygen saturation and was intended for use in hospital and surgical environments. The company became publicly traded in 1991, holding an initial public offering in March of that year and raising $4.5 million. Somanetics’ early commercial history was closely tied to U.S. medical-device regulation. In May 1993, it began marketing the INVOS 3100 after FDA approval. In November of the same year, however, the FDA revoked the marketing authorization because of concerns about the clinical-trial information included in the 510(k) submission. Somanetics later secured approval for the INVOS 3100A in 1996 and for the INVOS 5100 in 2000, allowing the company to continue developing its monitoring business. A major expansion occurred in 2006, when the FDA approved use of the INVOS monitor for sites beyond the cranium. This broadened the platform’s clinical scope to include additional parts of the body and supported the company’s positioning around both cerebral and somatic oxygenation monitoring. In 2008, Somanetics acquired ICU Data Systems, a Gainesville, Florida company, for $2 million. ICU Data Systems held a patented bedside-monitor design called Vital Sync, which could consolidate information from devices such as ventilators and infusion pumps. Somanetics also obtained FDA approval for the INVOS 5100C during 2008. By 2009, the INVOS system was reported to be used in approximately 700 hospitals in the United States and 1,200 hospitals outside the United States. This adoption indicated that the company had developed an international medical-device presence despite its specialized product category. In May 2010, the FDA authorized expanded functionality for Vital Sync. The changes included interfaces for a wider range of medical devices, presentation of derived parameters, and alerts when measurements exceeded configured thresholds. Somanetics agreed in 2010 to be acquired by Covidien for $250 million. In connection with the acquisition, Somanetics announced that it would close its Michigan and Florida operations. The transaction ended the company’s independent public-company phase, while its technology and products continued within Covidien. In 2015, Medtronic acquired Covidien and assumed ownership of the former Somanetics assets. The Somanetics corporate brand subsequently became less prominent, but Medtronic retained and continued producing INVOS monitors and sensors for healthcare use. The company’s lasting contribution is therefore represented primarily by the INVOS technology and product line rather than by an independent Somanetics operating organization.

• 2015

  Assets transferred to Medtronic

  [1]Somaneticsen.wikipedia.org

  Medtronic acquired Covidien and inherited the Somanetics assets and INVOS franchise.

• 2010

  Vital Sync functionality expanded

  [1]Somaneticsen.wikipedia.org

  FDA approval expanded Vital Sync interfaces, derived-parameter displays, and threshold-based clinical alerts.

• 2010

  Acquired by Covidien

  [1]Somaneticsen.wikipedia.org

  Covidien agreed to acquire Somanetics for $250 million; Somanetics subsequently announced closures of its Michigan and Florida operations.

• 2008

  ICU Data Systems acquired

  [1]Somaneticsen.wikipedia.org

  Somanetics acquired ICU Data Systems for $2 million, adding the Vital Sync bedside-monitoring platform.

• 2008

  INVOS 5100C approved

  [1]Somaneticsen.wikipedia.org

  The company received FDA approval to market the INVOS 5100C in the United States.

• 2006

  INVOS indication expanded

  [1]Somaneticsen.wikipedia.org

  FDA approval expanded the use of INVOS monitoring from the cranium to additional body sites.

• 2000

  INVOS 5100 approved

  [1]Somaneticsen.wikipedia.org

  The FDA approved the INVOS 5100 system for marketing in the United States.

• 1996

  INVOS 3100A approved

  [1]Somaneticsen.wikipedia.org

  Somanetics received U.S. FDA approval to market the INVOS 3100A system.

• 1993

  INVOS 3100 introduced and authorization revoked

  [1]Somaneticsen.wikipedia.org

  The company began marketing the INVOS 3100 after FDA approval, but the FDA revoked the marketing authorization later that year over concerns about clinical-trial data in the 510(k) submission.

• 1991

  Initial public offering

  [1]Somaneticsen.wikipedia.org

  Somanetics completed an initial public offering and raised $4.5 million; its shares traded on NASDAQ under SMTS.

• 1982

  Somanetics founded

  [1]Somaneticsen.wikipedia.org

  Gary Lewis founded Somanetics to commercialize optical technology for monitoring oxygenation in the brain and peripheral tissues.

Somanetics positioned itself as a specialized medical-technology company focused on continuous, noninvasive monitoring of regional tissue oxygenation and integration of bedside clinical data. Its INVOS systems were aimed at helping clinicians observe cerebral and somatic oxygenation during surgery and other hospital-care settings.

• Regional tissue oxygenation monitor · 1993

  INVOS 3100

  The INVOS 3100 was an early Somanetics monitoring system based on the company’s In Vivo Optical Spectroscopy technology. It was designed to provide clinicians with information about regional oxygenation, initially emphasizing cerebral monitoring during surgical procedures. Although its marketing authorization was revoked by the FDA in 1993 over concerns about submitted clinical-trial data, it established the product family that Somanetics later developed through subsequent approved systems.

• Regional tissue oxygenation monitor · 1996

  INVOS 3100A

  The INVOS 3100A was a later version of Somanetics’ regional oxygenation-monitoring platform. It received U.S. FDA approval in 1996 and represented the company’s continued effort to provide noninvasive optical monitoring of tissue oxygen saturation in clinical settings. The system followed the regulatory difficulties surrounding the original INVOS 3100 and formed part of the company’s successive monitor generations.

• Regional tissue oxygenation monitor · 2000

  INVOS 5100

  Approved by the FDA in 2000, the INVOS 5100 was a later-generation Somanetics monitor for observing regional tissue oxygenation. Its technology was intended for use by clinicians during surgery and other hospital-care situations where changes in cerebral or somatic oxygenation could be clinically relevant. It became one of the company’s principal commercial systems before the later 5100C version.

• Regional tissue oxygenation monitor · 2008

  INVOS 5100C

  The INVOS 5100C was an updated regional oxygenation-monitoring system approved for U.S. marketing in 2008. It belonged to the INVOS family developed by Somanetics to measure tissue oxygenation through optical spectroscopy. The platform reflected the company’s broader clinical scope after regulatory authorization had expanded INVOS use beyond the cranium to additional body sites.

• Bedside monitoring and device-integration platform · 2008

  Vital Sync

  Vital Sync was a bedside-monitoring technology obtained through Somanetics’ 2008 acquisition of ICU Data Systems. It was designed to integrate information from multiple medical devices, including ventilators and infusion pumps. FDA-cleared functionality added interfaces for more device types, derived-parameter displays, and configurable alerts when measurements exceeded selected thresholds, extending Somanetics beyond oxygenation monitoring.

• Medical monitoring system

  INVOS sensors and monitors

  The INVOS franchise continued after the acquisition of Somanetics and is associated with sensors and monitors used to assess regional tissue oxygenation in healthcare environments. Medtronic inherited the product assets through its 2015 acquisition of Covidien and continues to produce INVOS-branded equipment, making this the surviving commercial expression of Somanetics’ principal technology.

• 2010

  Agreement to be acquired by CovidienM&A

  Background

  Somanetics had an established INVOS franchise and had recently expanded into bedside device integration through Vital Sync.

  Action taken

  Somanetics agreed to be acquired by Covidien for $250 million.

  Aftermath

  Somanetics ceased operating as an independent company, and its Michigan and Florida operations were announced for closure. The assets later passed to Medtronic through its acquisition of Covidien.

  Acquisition value. $250 million (2010)

  Source

• 2008

  Acquisition of ICU Data SystemsM&A

  Background

  Somanetics sought to broaden its medical-monitoring portfolio beyond regional oxygenation measurement. ICU Data Systems owned Vital Sync, a patented bedside platform for integrating data from multiple medical devices.

  Action taken

  Somanetics acquired ICU Data Systems for $2 million and added Vital Sync to its product portfolio.

  Aftermath

  The acquisition gave Somanetics a device-integration and clinical-alert offering alongside the INVOS monitoring business.

  Acquisition price. $2 million (2008)

  Source

1. 1Somaneticsen.wikipedia.org