Medline Joins Forces with Potrero Medical to Transform Critical Care Monitoring

Precision Data Guides Precision Medical Interventions; Reduces CAUTI Risk

Northfield, Ill. Jan. 23, 2017 — Medline Industries, Inc., a leading global healthcare manufacturer and distributor, and Potrero Medical, Inc., a privately held medical device company and the developer of the Accuryn™ critical care monitoring system, today announced a joint partnership to expand commercialization and continue clinical investigations to further support the benefits of the Accuryn critical care monitoring system. With this agreement, Medline has secured long-term exclusivity for marketing and distribution of Accuryn in North America. The ability to leverage Medline’s extensive reach in the acute care hospital market ensures that as many critical care physicians and nurses as possible will have access to this state-of-the-art system that empowers clinicians with more accurate and easily accessible data.

“We are pleased to partner with Medline to commercialize the world’s only technology capable of providing accurate, real-time data related to urine production and intra-abdominal pressure – the Accuryn Monitoring System.” says Dr. Daniel Burnett, chief executive officer of Potrero Medical. “Medline’s reputation as a market leader combined with their impressive customer base will quickly make the Accuryn critical care monitoring system available to thousands of hospital systems and millions of patients in the United States.”

“Medline is committed to being the leading supplier of clinically innovative solutions to healthcare providers. Our partnership with Potrero Medical on the Accuryn Monitoring System fully demonstrates this commitment and sets the pace for a new standard in critical care monitoring. We look forward to presenting this new technology to leading intensivists and critical care nurses at this month’s Society of Critical Care Medicine Annual Congress,” says David Greenberg, executive vice president of strategy and group president, Medline.

About the Accuryn System

Accuryn is a critical care monitoring system that transforms the traditional urinary catheter into a next-generation diagnostic tool.  Accuryn uses proprietary electromechanical designs and advanced software algorithms to deliver automated, real-time actionable data including urine output, core body temperature and intra-abdominal pressure (IAP). The IAP measurement is taken directly from the catheter tip with just a push of a button, reducing setup time, potential errors, and infection risk. Additionally, innovative active drain line clearance overcomes urine drainage issues that can make urine output measurements unreliable.

The Accuryn™ System is a 510(k) cleared medical device available for sale in the United States.

For more information on Accuryn, visit www.AccurynFromMedline.com?cmpid=RID:MN:Accuryn:1/23/2017.

About Medline

Medline is a global manufacturer and distributor serving the healthcare industry with medical supplies and clinical solutions that help customers achieve both clinical and financial success. Headquartered in Northfield, Ill., the company offers 350,000+ medical devices and support services through more than 1,200 direct sales representatives who are dedicated points of contact for customers across the continuum of care.  For more information on Medline, go to www.medline.com or http://www.medline.com/social-media to connect with Medline on its social media channels.

About Potrero Medical, Inc.

Potrero Medical, Inc., the latest spinout of medical device incubator Theranova, LLC, is headquartered in San Francisco, CA and was founded with a mission to improve outcomes, reduce costs and expand access to healthcare. For more information about the company, please visit www.potreromed.com.

Potrero Medical, Inc. Receives FDA Clearance for the Accuryn™ Monitoring System

Product Launch at American Burn Association Conference in Las Vegas, May 3rd-6th

SAN FRANCISCO, April 26, 2016 /PRNewswire/ — Potrero Medical, Inc. announced today that it received 510 (k) clearance through the Food and Drug Administration (FDA) for the company’s Accuryn™ Monitoring System, which transforms the traditional urinary catheter into a next-generation diagnostic tool for patients requiring tight fluid management, including patients at risk of sepsis and acute kidney injury.

Accuryn™ provides accurate, real-time urine output (UO), intra-abdominal pressure (IAP), and temperature measurement. By automatically clearing the drain line, Accuryn™ enables accurate UO and reduced urinary retention – a known risk for catheter associated urinary tract infection (CAUTI). Accuryn™ is also designed to improve clinical workflow by eliminating manual intervention of drain line blockages and by providing out-of-the box EMR integration.

“Urine output monitoring is a very important field that has stagnated for decades. Based on my personal experience using Accuryn™ in our burn unit, I can say that this device establishes a new state of the art,”  Said Bruce Friedman, clinical care co-director of the Joseph M. Still Burn Center.  “Accuryn™ is able to eliminate urinary outflow obstruction that is ubiquitous in current urine drainage systems.  Solving this problem significantly improves the accuracy and diagnostic value of urine output monitoring and also prevents urinary retention- a major risk factor for CAUTI.”

Potrero Medical, Inc. has demonstrated superiority of Accuryn™ in a multicenter randomized clinical study of Accuryn™ against the current gold standard device. The company is currently engaged in a multi-center study of Accuryn™ to detect sepsis and critical illness (PRESCIENT), which is projected to enroll up to 100 patients in the United States.

Daniel Burnett, MD, Founder and CEO of Potrero Medical stated, “Sepsis and Acute Kidney injury accounted for over $25 Billion in US healthcare costs in 2011 and these costs are growing unsustainably. The Accuryn device will provide actionable data to clinicians which will enable them to improve patient outcomes and to reduce the financial burden of these critical illnesses.”

Potrero Medical will exhibit the Accuryn Monitor at the American Burn Association 48th Annual meeting at Caesar’s Palace, Las Vegas, NV between May 3rd-6th 2016.  For more information, please visit http://www.ameriburn.org.

The Accuryn Monitoring System – Important information

The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short-term use (less than 30 days).

For information on purchasing Accuryn, please contract Potrero Medical at (415)-926-8616 or sales@potreromed.com.

About Potrero Medical, Inc.:

Potrero Medical, Inc., the latest spinout of medical device incubator Theranova, LLC, is headquartered in San Francisco, CA and was founded with a mission to improve outcomes, reduce costs and expand access to healthcare. For more information about the company, please visit www.potreromed.com.

WellMed CEO George M. Rapier, III, M.D. Joins Board of Directors of Potrero Medical

SAN FRANCISCO, Feb. 11, 2016 /PRNewswire/ — Potrero Medical, Inc., the developer of the Accuryn™ critical care monitoring system, is pleased to announce the appointment of George M. Rapier, III, MD, to its Board of Directors.

Dr. Rapier is a distinguished clinician, entrepreneur and philanthropist who serves as Chairman and CEO of WellMed Medical Management, Inc.  Headquartered in San Antonio, TX, WellMed is one of the nation’s largest physician owned practice management companies, servicing over 200,000 patients and HMO members in Texas and Florida.    Since founding WellMed in 1990 out of his own internal medicine practice, he has been instrumental to the company’s growth into a multi-billion dollar business focused on continuously improving patient care.  Dr. Rapier developed and has continued to work with specialists to implement disease management programs to enhance the quality of life for WellMed patients.   He led the development of clinical health protocol screening systems to access and evaluate clinical, lab and medication data, assisting in providing preventive health and screening recommendations to physicians, and was a pioneer in the implementation of electronic health records. In September 2009 Modern Physician Magazine named Dr. Rapier Physician Entrepreneur of The Year.    Through the Rapier Charitable Trust and the WellMed Charitable Foundation, Dr. Rapier and his wife, Kym, have provided millions of dollars in grants to support educational, health, and social welfare causes in the San Antonio, TX area.

“Potrero Medical’s technology presents an exciting new opportunity to improve outcomes and lower the cost of care for a wide range of critically ill patients.  I am excited to join with management to put this potentially life-saving technology into the hands of care-givers worldwide,” said Dr. Rapier.

Daniel Burnett, MD, Founder and CEO of Potrero Medical stated, “Dr. Rapier is a tremendous addition to our Board of Directors. We expect to benefit greatly both from his deep understanding of care delivery for the patient populations that we are targeting and his experience in introducing impactful new technologies.”

About the Accuryn™ System:

Accuryn™ is a critical care monitoring system that transforms the traditional urinary catheter into a next-generation diagnostic tool.  Accuryn uses proprietary electromechanical designs and advanced software algorithms to deliver automated, real-time actionable data including urine output, core temperature and intraabdominal pressure.

Potrero Medical, Inc. has demonstrated superiority of Accuryn™ in a multi-center randomized clinical study of Accuryn™ against the current gold standard device. The company is currently engaged in a multi-center study of Accuryn™ to detect sepsis and critical illness (PRESCIENT), which is projected to enroll up to 100 patients in the United States.

The Accuryn™ System is currently an investigational medical device and is not for sale in the United States.

About Potrero Medical, Inc.:

Potrero Medical, Inc., the latest spinout of medical device incubator Theranova, LLC, is headquartered in San Francisco, CA and was founded with a mission to improve outcomes, reduce costs and expand access to healthcare. For more information about the company, please visit www.potreromed.com

Potrero Medical Commences NIH-backed PRESCIENT Study of Accuryn™ For Early Detection of Critical Illness

SAN FRANCISCO, Feb. 2, 2016 /PRNewswire/ — Potrero Medical, Inc. today announced the start of the PRESCIENT study, an NIH-sponsored, multi-center observational study using the Accuryn™ Monitoring System to detect the physiological signatures of critical illnesses, including sepsis.

Professor Raul Coimbra, MD, the lead investigator for the study and Chief of the Division of Trauma Surgery at the University of California San Diego, Hillcrest, stated, “We are excited to have enrolled our first patient in the PRESCIENT study which will contribute significantly to the understanding of the physiologic signatures of a variety of critical illnesses in the ICU.  This understanding may ultimately lead to earlier detection, and possibly even prediction, of these highly morbid and costly illnesses.”

“This study is intended to test the Accuryn system as a potential new tool for patient monitoring and treatment in the ICU.  The device has the potential to provide an early indication of sepsis and, perhaps more importantly, future studies of the additional capabilities of this device could lead to actionable data in guiding resuscitation,” said Phillip Dellinger, MD, Chief of Medicine at Cooper University Health Care in Camden, NJ and Clinical Advisor to Potrero Medical.

Daniel Burnett, MD, Founder and CEO of Potrero Medical stated, “Initiation of this study is another important milestone for us and another step on the path to creating what we believe will be a new gold standard diagnostic platform for the detection and treatment of critical illness.  We are thrilled to have the support of Dr. Coimbra, Dr. Dellinger and other leaders in critical care who share our vision for Accuryn™ as a potentially life-saving and cost-saving solution.”

Potrero Medical was awarded $2.25M in SBIR grants from the NIH’s National Institute of General Medical Sciences to run the multi-center PRESCIENT study which is projected to enroll up to 100 patients in the United States.

About the Accuryn™ System:

Accuryn™ is a critical care monitoring system that transforms the traditional urinary catheter into a next-generation diagnostic tool.  Accuryn uses proprietary electromechanical designs and advanced software algorithms to deliver automated, real-time actionable data including urine output, core temperature and intraabdominal pressure.

Potrero Medical Inc. previously demonstrated superiority of Accuryn™ in a multi-center randomized clinical study of Accuryn™ against the current gold standard device.  The Accuryn™ System is currently an investigational medical device and is not for sale in the United States.

About Potrero Medical, Inc.:

Potrero Medical, Inc., the latest spinout of medical device incubator Theranova, LLC, is headquartered in San Francisco, CA and was founded with a mission is to improve outcomes, reduce costs and expand access to healthcare. For more information about the company, please visit www.potreromed.com.