Paragonix Technologies, Inc., a medical device company based in Braintree, MA, developing the Sherpa™ product line for organ preservation and transportation, today announced that the Company's $1.1M convertible debt round has been successfully closed. "This financing enables the company to execute on our strategic and development plans under a capital efficient business model," noted Bill Edelman, Paragonix's Chairman and CEO. "We look back on 2013 as a highly productive year, with one 510(k) FDA Pre-market Notification clearance received in February and two additional 510(k) FDA submissions filed, expanding the Sherpa product line."
To date the Company has raised $3.4M in equity, debt financing, and NIH grants and has produced one 510(k) regulatory clearance and two additional FDA submissions. This compares favorably to a recent PriceWaterhouse Coopers, LLP (PWC) survey of over 200 medical device companies, which averaged 10 months for 510(k) Pre-market clearances received with associated spending of nearly $31M in average total regulatory costs.
Tom Sommer, President of Massachusetts Medical Device Industry Council (MassMEDIC), commented, "With the reduction in capital and sources for early stage medical device companies, these businesses have to be more capital efficient to get to market. Obviously Paragonix has successfully executed this principle by achieving three submissions on less than $5M in capital."