Wednesday October 12, 2016 0 comments
GOLDEN -- A Golden-based medical device company is aiming to dramatically reduce the number of people dying every year from pulmonary embolisms (PEs) caused by blood clots lodging in their lungs.
Bio2 Medical, founded in 2006 by Dr. Luis Angel, Paul Castella and Christopher Banas, is offering the Angel® Catheter – named after its inventor, Dr. Luis Angel – to physicians who are wary of using traditional inferior vena cava (IVC) filters and anti-coagulation therapy for patients with traumatic brain injuries and active bleeding.
CEO Banas says pulmonary embolisms are “silent killers” that lead to up to 340,000 deaths in the U.S. alone each year. Banas says blood clots usually form in the veins of the legs after trauma and can sometimes break loose and travel to the lungs.
“This is intended to protect critically ill patients that are contra-indicated for anti-coagulation therapy,” Banas said of the Angel Catheter.
As an example, Banas cites the hypothetical case of a motor vehicle accident victim admitted to the hospital ICU with a traumatic brain injury and/or long-bone fractures.
“That patient is at very high risk of a pulmonary embolism,” he said. “Typically, physicians prescribe blood-thinning agents for trauma patients, but patients often cannot receive blood thinners due to their high risk of bleeding. For this reason, the patient is left unprotected when they are at their highest risk for developing a PE.
Banas says physicians have been inserting traditional inferior vena cava filters into patients’ bodies to try to prevent a pulmonary embolism -- but there’s a big problem with that.
“These filters are very effective at capturing clots,” he said. “The problem is these filters are not typically placed till Day 7, 8 or 9. Until then, that patient is completely unprotected.” Further complicating the situation is the fact that the traditional filters are removed only 34 percent of the time, which can lead to filter migration and potential patient death. The Angel Catheter was designed to mitigate the complications commonly associated with traditional filters, Banas said.
“Dr. Angel invented a filter which is permanently attached to a catheter, which guarantees filter retrieval,” he said.
“So if the physician places the device at the bedside in the ICU, that patient can benefit from having immediate, PE prophylaxis at hour zero."
First-ever FDA designation
Banas said the U.S. Food and Drug Administration (FDA) has granted Bio2 Medical the first-ever designation for a prophylactic indication in critically-ill patients. The market opportunity for such patients is approximately 1 million people each year in the U.S. alone.
Bio2 Medical recently launched the Angel Catheter and hired six sales managers to sell the device nationally. The company now employs 36 people with 27 located in Colorado.
Banas said the catheter is “being received very well” and the company is now educating hospitals and physicians on its use and availability. Not only does it hold the potential to save thousands of lives every year, but the device can also help lower health costs.
“It’s going to save the health care system money,” Banas said, noting that the cost of treating a pulmonary embolism ranges from $20,000 to $50,000 per patient.
“Prevention of pulmonary embolisms saves lives and money,” he said.
Bio2 Medical recently announced its Angel Catheter was placed in two patients at St. Mary's Medical Center in West Palm Beach, Fla., by Lawrence Lottenberg, MD FACS, and Robert Borrego, MD FACS, on Sept. 29.
It is the first commercial usage of the Angel Catheter and St. Mary's Medical Center of Tenet Health is the first hospital in the United States to place the device, the company said.
"The Angel Catheter provides an unmet need for a prophylactic indication for the prevention of pulmonary emboli,” said Lottenberg.
“Unlike traditional filters, the Angel Catheter cannot migrate from its deployment position, and it is easily inserted and easily removable for patients who cannot be prophylactically anticoagulated during the immediate and early phases of injury.
“There are none of the complications seen in the many currently available inferior vena cava filters. This makes the device unique and one of a kind. The recognition of the value of this technology to patient safety and patient care by the Tenet Healthcare System and St. Mary's Hospital in bringing this technology to our Level I trauma cannot be overstated."
"The placement of the Angel Catheter at the bedside is a safe and efficient way to protect patients at high risk for pulmonary embolism, who cannot be anticoagulated for seven to ten days, therefore protecting them from additional morbidity/mortality due to pulmonary embolism in high-risk patients," said Dr. Borrego.
More than $50M raised
Banas said Bio2 Medical has so far raised more than $50 million in equity and venture debt financing.
“I am in the process of raising a $20 million round that will go toward our commercialization effort,” he said, with the new funding targeted to hire additional sales people, buy raw materials and fund other business infrastructure, including ramping up its state-of-the-art manufacturing facility in Golden.
Banas said Bio2 Medical is currently focused on promoting and selling the Angel Catheter in the U.S.
He said the company is planning to offer more medical device products in the future.
“We have quite a few R&D products in the pipeline that we can’t talk about right now,” Banas said. “We’re looking at the market to tell us what they want.”
Banas said Bio2 Medical would not be where it is today without the help and support of the Colorado BioScience Association (CBSA).
“The Colorado BioScience Association led by April Giles has been very helpful to us, and I think they are doing a fantastic job.”
To view a video of how the Angel Catheter works, click here.