Paragonix Technologies, Inc. , a medical device company developing the Sherpa product line for organ preservation and transportation, said 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, Paragonix said that it 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 (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.1 Tom Sommer , President of Massachusetts Medical Device Industry Council (MassMEDIC), said, "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." The Massachusetts Medical Device Industry Council (MassMEDIC) is an organization of medical device manufacturers, suppliers and associated non-profit groups in Massachusetts and the surrounding region. Paragonix previously announced on December 17 , filing of a 510(k) Pre-market Notification Application with the US Food and Drug Administration for the Paragonix Sherpa Pak Transporter. Paragonix previously announced on November 18 , the filing of a second 510(k) Pre-market Notification Application with the US Food and Drug Administration for the Paragonix Sherpa Cardiac Transport System. Paragonix previously announced on July 22 , publication by the ASAIO ( American Society for Artificial Internal Organs ) Journal of "Oxygen Consumption during Oxygenated Hypothermic Perfusion as a Measure of Donor Organ Viability." Paragonix previously announced on June 10 , presentation of "An Innovative, Novel Hypothermic Storage System For Donor Hearts," discussing the Sherpa Pak Cardiac Transport System during the 16th Congress of the European Society for Organ Transplantation held in Vienna, Austria , 8th - 11th September 2013 . Paragonix previously announced on February 12 , clearance of a 510(k) Pre-market Notification Application with the US Food and Drug Administration for the Paragonix Sherpa Cardiac Transport System. Paragonix previously announced on July 16, 2012 , award of a Phase I Small Business Innovation Research (SBIR) Grant to support the pre- clinical development of the Paragonix Sherpa Cardiac Transport in collaboration with the Transplant Center at Massachusetts General Hospital ( Boston ). Paragonix previously announced on June 25, 2012 , appointment of Leonard A. R. Golding, MB, BS, FRACS, FRCS(C), FACC as Chief Medical Officer. Paragonix previously announced on June 18, 2012 , formation of a Clinical Advisory Board for the Paragonix Sherpa Cardiac Transport System . Currently, the availability of organs for transplantation is governed by the "ischemic time," that being the elapsed time from organ donation to recipient implantation. Paragonix Sherpa is designed to be used in conjunction with any of the currently available organ preservation solutions. Paragonix Sherpa is fully disposable, eliminating problems associated with maintenance, device transport and contamination. Paragonix Sherpa is intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for implantation. The Sherpa Pak CTS is intended for transport of hearts and the Sherpa Pak Transporter is intended for transport of kidneys within the time frame currently considered as routine medical practice. ((Comments on this story may be sent to firstname.lastname@example.org ))
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