A Brief Company History

It's amazing how quickly the time has passed here at MicroPhage. Focused on clincial product development for just over two years, the company is now quickly ramping up efforts to validate inital products in clinical laboraotries and look forward to FDA clearance in 2009. Here is a brief history of the company, focusing on major development and financing milestones.

2002
MicroPhage was founded and incorporated as a Delaware corporation in June 2002 by Jack Wheeler and Kent Voorhees, Ph.D., to commercialize a bacteriophage-based bacterial detection technology exclusively licensed from the Colorado School of Mines. The technology transfer marked the first such license by the University.

2003
The company was funded initially through a small Seed Capital raise in 2003.

Originally based upon the detection of the bacteriophage specific capsid protein with MALDI-TOF Mass Spectrometry, the company quickly demonstrated the reliability and ease of use of detecting bacteriophage amplification with alternative methods including; lateral flow immunochromatography (LFI), enzyme linked Immunosorbant assay (ELISA), optical immunoassays (OIA) and real-time polymerase chain reaction (RT-PCR). MicroPhage and its first four employees were initially located on the campus of the Colorado School of Mines.

2004
The issuance of $1,050,000 in convertible debt, provided through a small group of angel investors, led by the Alpine Angels of Vail, Colorado. Payroll opens in January with 4 employees (2 in R&D).The company leverages lab space at the University for initial proof of concept efforts in E. coli and Salmonella. In November of 2004, the company moved to a new 5,000 sq. ft. location in Longmont Colorado and expanded to 7 employees, 5 in R&D. The company focus was on the development of a rapid (sub 12 hour) Salmonella sp. assay for direct detection from poultry meat and wash.

2005
The company successfully demonstrated that its bacteriophage-amplification based diagnostic platform could help protect the food supply with an 8-10 hour test for Salmonella sp., starting with the requisite 1 CFU per 25g sample. Although successful in achieving its goal, the company realized that the true value of the technology could not be realized in a market with such high price pressures. For those interested, licensing of this product is available.

The company expanded to 11 employees (8 in R&D), and by Q3 2005, shifted its development efforts away from food and industrial product detection to research and development efforts for the identification of S. aureus, E. coli, and S. pneumoniae in clinical applications.

2006
The company completed a Series A-1 preferred stock financing through the issuance of more than $3.5M Series A preferred Stock in June, completely financed again with angel investors. The foundation of a quality assurance and clinical trial group were established to assist the company in its drive to meet product introduction.

The company narrowed its development focus from three to one clinical targets, S. aureus, and determined that the test of highest clinical value would be for direct identification of this organism from blood cultures. Drew Smith joined MicroPhage as the Research and Development Director, and with colaboration with notable S. aureus researchers, transformed the laboratory development into a highly performing assay with almost absolute specificity and high sensitivity. The year closes with 10 employees (7 in R&D, 2 PhDs).

2007
Focused on transferring the laboratory research efforts of identification of S. aureus from blood cultures to a product development position, MicroPhage hired Michael Fiechtner as Director of Product Development from BD Diagnostics. The product portfolio expanded when the R&D group successfully demonstrated high performance in determining antibiotic susceptibility and resistance for this organism in blood culture and nasal swab models. Development continued with more than 500 clinical strains of Staphylococci on these two products while immunoassay detectors and user-friendly sampling devices were being designed.

Reinvigorated with this success, the company financed a Series A-3 round, again solely with Angel investors, for just over $2.5M in November 2007, bring the angel-financed total to more than $7.2M, the largest known angel-investment in medical diagnostics. The year closes with 13 full-time employees (10 in R&D, 3 PhDs).

2008 and beyond...
Although the future is not history, it is always good to know where a company is headed. Slated for 2008 are a series of larger clinical studies of the company's two leading products for S. aureus / MSSA / MRSA identification at a number of premier clinical sites throughout the US. Full FDA-required Clinical Trials are slated to begin late in the year, pending FDA and CMS (Centers for Medicare and Medicaid) design input. The company will begin additional indications for its current test, as well as develop its bacterial and antibiotic testing pipelines with additional research efforts launching in Q2 2008. The company exects to have product cleared by the US FDA in 2009 and CE Marking the same year to support local and international sales.