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Visby Medical

www.visbymedical.com link_icon

Company Research Report: Visby Medical, Inc.



Company Overview



  • Name: Visby Medical, Inc.

  • Mission: No information available.

  • Founding: Founded by Adam de la Zerda, PhD. Specific founding year is not provided.

  • Key People:

  • Adam de la Zerda, PhD, Founder & CEO

  • Gary Schoolnik, MD, Chief Medical Officer

  • Tony Allen, SVP of Manufacturing & Operations

  • Beth Lingenfelter, SVP of Quality, Regulatory, and Clinical Affairs

  • Headquarters: 3010 North First Street, San Jose, CA 95134

  • Number of Employees: No information available.

  • Revenue: No information available.

  • Known For: Visby Medical is known for its rapid, point-of-care PCR testing technology designed to provide fast, accurate diagnostic results directly in clinical settings.


Products



1. Sexual Health Test


  • Description: Provides rapid PCR testing for sexually transmitted infections (STIs) allowing for immediate results at point-of-care.

  • Key Features:

  • Reduces traditional lab wait times from 6 days to under 30 minutes.

  • Portable, handheld device size reduced significantly from traditional lab instruments.

  • Identifies pathogens rapidly, helping in improving treatment choices and reducing over- and under-treatment rates.


2. Respiratory Health Test


  • Description: Designed to identify respiratory infections quickly and accurately to facilitate immediate treatment decisions.

  • Key Features:

  • Authorized for use in CLIA waived settings ensuring broad accessibility.

  • Aid in accurate and timely diagnosis at point of care to avoid patient callbacks and improve patient management.


Recent Developments



  • New Products and Features:

  • February 16, 2024: CARB-X awarded Visby Medical up to $1.8 million to develop a PCR test capable of detecting and assessing gonorrhea susceptibility to ciprofloxacin.

  • January 3, 2023: FDA Emergency Use Authorization was granted for the Respiratory Health Test for use in CLIA waived settings.

  • March 14, 2023: Received FDA 510(k) clearance and CLIA waiver for its second-generation Sexual Health Test.

  • March 25, 2022: Secured $25.5 million from BARDA to develop an at-home rapid Flu-COVID PCR test.


  • Achievements and Collaborations:

  • May 30, 2024: Published results demonstrate significant improvements in STI treatment practices with their Sexual Health Test.

  • June 15, 2022: Selected as a finalist for AACC's Disruptive Technology Award recognizing its diagnostic technology.

  • April 4, 2022: Partnered with Chiricahua Community Health Centers, Inc., to provide the Sexual Health Test at the US-Mexico border for same-day results.


  • Corporate Developments:

  • March 1, 2022: Successfully raised over $100 million in Series E financing to advance development of its diagnostic technologies.

  • May 25, 2022: Everett Cunningham appointed to the Board of Directors as part of its corporate expansion.

  • June 29, 2022: Expanded Series E funding round to over $135 million.


  • Strategic Directions:

  • Continuous focus on creating rapid, single-use diagnostic technologies for point-of-care and potentially at-home use.

  • Actively engaging in partnerships and funding opportunities to accelerate product development and expand market presence.


This report summarizes the available information about Visby Medical, Inc., emphasizing its innovative approach in diagnostic testing and strategic developments to enhance healthcare delivery systems.