Blog

February 12, 2019
regenmed-sa-blog-1

This year’s RegenMed SA conference at the Wyndham Riverwalk brought the biomedical community together to talk about regenerative medicine research happening in local universities and research labs.

Participation in the event – more than 200 people registered, the most in its five-year history – demonstrated the interest in regenerative medicine in the region.

But Becky Cap, Chief Operating Officer of GenCure and one of the conference’s organizers, said the event was far more than a show of interest in a growing field.

February 11, 2019
medical-device-process-blog

The Food and Drug Administration has proposed new guidance for the approvals process for medical devices.

For more than 40 years, device makers obtained an expedited approval if they could prove the new device was “substantially equivalent” to one in use when the regulation went into effect in 1976, according to a report by CNBC.

The change is designed to encourage manufacturers to base new products on devices no older than 10 years.

The change will not directly affect BioBridge Global and its subsidiaries, as we don’t manufacture or market medical devices at this time directly, said Adrienne Mendoza, Vice President for Global Quality & Compliance.

February 4, 2019
brothers-in-arms-3

For patients like George Ortiz, the program has been lifesaving.

Ortiz, a construction worker from Jourdanton, suffered a severe leg injury last year while on the job, causing a dramatic loss in blood.

“What I remember is standing on top of the hole-drilling machine and removing some pins so that the rest of the stem that drills the hole could come down. Then the machine squished my leg. It felt like it tore it off," he said.

January 28, 2019
blood-cancer-survival-rates-blog

Survival rates for patients with blood cancers like leukemia and lymphoma – diseases that not that long ago were considered all but incurable – have increased dramatically.

According to the Leukemia & Lymphoma Society, the five-year survival rates for patients diagnosed with leukemia from 1960-63 was just 14 percent. Fifty years later, it reached 61 percent.

For Hodgkin lymphoma, the five-year survival rate has gone from 40 percent to 88 percent. Five-year survival rates for non-Hodgkin lymphoma has also improved from 31 percent to 73 percent since the 1960s.

“I can’t help but be proud and gratified that I work for an organization that has helped improve the survival rate of blood cancers,” said Dr. Rachel Beddard, Chief Medical Officer at BioBridge Global.

January 21, 2019
platelet-guidelines-blog

Proposed new guidelines from the Food and Drug Administration have the potential to alter the way blood centers handle platelets destined for patients.

The draft guidance, “Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” would replace a draft guidance issued in March 2016.

The updated guidelines are designed to control the risk of bacterial contamination of room temperature platelets, said Dr. Samantha Gomez Ngamsuntikul, associate medical director at BioBridge Global. Platelets donations that are four or five days old are associated with a higher risk of negative reactions in patients.

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