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The Eunice Kennedy Shriver National Institute of Child Health & Human Development has awarded a $256,000 grant to BioAesthetics Corp., a Tulane University spin-out company, to develop a new graft for treating pelvic organ prolapse, according to a Tulane.edu news release.
BioAesthetics, whose CEO and COO are both Tulane graduates, is collaborating with Tulane researcher Kristin Miller, an associate professor of biomedical engineering whose lab will conduct the testing of the graft.
The grant is part of the National Institutes of Health Small Business Innovation Research program, which funds research that has strong potential for technology commercialization.
Female pelvic organ prolapse is a condition where pelvic floor muscles or connective tissues fail to support the pelvic organs. Worldwide, pelvic organ prolapse affects 33 to 50% of all women, who often experience incontinence, frequent urinary tract infections, bleeding and pain.
Approximately 12% of all women with the condition will need surgery for pelvic organ prolapse, the goal of which is restore organs to their original positions. The procedure typically uses stitches, synthetic mesh implants or grafted tissue to provide support, the news release states.
However, surgical success rates are low, with over 40% of vaginal pelvic organ prolapse surgeries using native tissue failing within two years. Synthetic meshes carry significant safety risks including chronic infection, nerve and tissue damage, and genital tearing; these risks are so serious that the use of surgical mesh was recently banned in the United States and several other countries.
“The suboptimal surgical outcomes are largely due to the fact that the female reproductive system is drastically understudied, limiting the ability of engineers to design effective treatments that match the properties of healthy tissues within the pelvic floor,” said Miller, who was recently awarded the 2021 ASME Y.C. Fung Early Career Award for her contributions in advancing the bioengineering fields’ understanding of the female reproductive system.
BioAesthetics’ novel graft, which is an acellular biologic graft strengthened with biodegradable, biocompatible polymers, will be tested in Miller’s lab to compare its elasticity and strength to that of normal tissue found in the pelvic floor and to evaluate the healing and performance of the graft in a rodent model.
“We are extremely excited to collaborate with Dr. Miller to test our novel biomaterial graft for the treatment of POP. Her expertise in the field is critical to properly evaluating the technology and advancing ultimately to the clinic to improve the quality of life for those suffering from POP,” said Nicholas Pashos, PhD, founder and CEO of BioAesthetics and principal investigator of the SBIR grant.
BioAesthetics’ mission is to transform lives through advancements in biomaterials, the news release states. Its first product is an acellular graft for regenerating the nipple and areola for breast cancer patients who have undergone mastectomy. The company is developing additional next-generation grafts for pelvic organ prolapse, burns and pressure ulcers to improve treatment outcomes and patients’ quality of life.

Staff Report
Standing beside physicians and hospital executives overwhelmed by COVID-19, Gov. John Bel Edwards announced Monday that masks will again be required in indoor public spaces statewide beginning Wednesday.
The mandate applies to people whether or not they’re vaccinated against the coronavirus and will be in effect until Sept. 1.
The mandate is the latest state response to the resurgence of COVID, which is spreading and putting people in hospitals faster than at nearly any other point in the pandemic. Public health officials blame the fourth wave on the highly transmissible and highly virulent Delta variant and low vaccination rates in some regions, including Louisiana.
“It’s clear that our current recommendations are not strong enough,” Edwards said Monday at a press conference in Baton Rouge.
St. Mary Parish President David Hanagriff said at Wednesday’s Parish Council meeting that he will not impose a parish-specific mask mandate here. Monday’s announcement by Edwards didn’t change his mind.
“While I understand where the governor’s coming from,” Hanagriff said in an interview Monday, “I personally don’t believe we need a mask mandate right now.”
Hanagriff went along with mask requirements and other mitigation measures early in the pandemic, when knowledge about the disease was uncertain and no vaccine had been developed, he said.
But “at this point in the game, I’m not in favor of a mask mandate, particularly for those who are vaccinated,” he said.
Hanagriff urged people to get vaccinated and said people who feel they need masks to protect themselves or their families should feel free to wear them.
The re-instituted mask mandate applies to everyone over 5, including students who return to school this month.
Dr. Teresa Bagwell, St. Mary superintendent, sent this message Monday after the governor’s press conference:
“My message to parents, students, and staff is to understand and adapt to the re-instituted mask mandate as it is a minor inconvenience that can make a major difference in the lives of others.
"The safety and well-being of our community is of utmost importance and as our students return to class, they are fully prepared and experienced in following COVID-19 guidelines that protect them and their families.
“The reissuance of a temporary mask requirement was anticipated, and schools are ready to implement the established health protocols that became common place last school year. An executive order from Washington already required students to wear masks on school buses.”
Young people must be at least 12 to be eligible for vaccination.
“It’s vitally important that we protect our children, especially those who are too young to be vaccinated,” Edwards said.
Dr. Mark Kline, a pediatric disease specialist at Children’s Hospital in New Orleans, sounded more alarm bells.
“I have to tell you I’m as worried about our children as I have ever been,” Kline said at Monday’s press conference.
Earlier COVID variants seemed to go easier on young people. Now Kline said the hospital is seeing 20 young COVID patients, with four to six in intensive care. Half the children with COVID had no underlying health condition that made them vulnerable to coronavirus infection.
With the mask mandate, “I feel we’ve been thrown a lifeline,” Kline said. “Schools will open, and now we have the tools to keep kids safe.”
Numbers
On Monday, the numbers that apparently persuaded Edwards to toughen mask rules included 11,109 new COVID cases on 81,000 tests; 27 deaths; and 1,984 COVID-positive people in hospitals.
The hospitalizations figure was an increase of 244 since Friday.
The increase in COVID infections shows no signs of slowing down, the governor said.
More COVID is in Louisiana than ever, Public Health Officer Dr. Joseph Kanter said.
The Delta variant is at least twice as transmissible as earlier variants. But, even though break-through infections are being reported among those who have been vaccinated, the vaccines significantly reduce the risk of becoming seriously ill or dying, Kanter said.

Filling up
Hospital staffers and executives from around the state said at Monday’s press conference that the growing number of COVID patients threatens their ability to care not just for people with coronavirus but for those with other illnesses and injuries, too.
Earlier in the pandemic, people shied away from emergency rooms because they feared COVID, said Dr. Phyllis Mason, chief medical officer at Natchitoches Regional Medical Center.
“Now people are comfortable with it,” Mason said.
The combination of COVID patients and those with other problems can mean a wait of three days or more in the emergency room, waiting for an in-patient bed, Mason said.
She urged people to get vaccinated and to wear masks.
“If you don’t trust the science,” she said, “at least respect the virus.”
Michele Sutton is president and CEO of North Oaks Health System in Hammond.
She said COVID among the hospital staff has been a problem, along with low morale.
“Our staff is seeing the deaths of young people,” Sutton said. “We’re not used to that.”
Dr. Catherine O’Neal is chief medical officer at Baton Rouge’s Our Lady of the Lake, Louisiana’s largest hospital.
She said the hospital had 36 COVID patients two weeks ago and now has 155 among 713 people admitted.
“No one disease should take up a quarter of our hospital,” O’Neal said.
“We need you to open beds for us. We need you to do that by getting vaccinated today and by putting your mask on today.”
O’Neal was raised on a farm and said she enjoys driving home from work and seeing farmers at work and young people on motorcycles and four-wheelers.
“These are my people,” O’Neal said.
“If they get maimed today, they’re not going to go to a trauma center because we don’t have any beds.”

Gov. John Bel Edwards announced Monday that his emergency proclamation will be amended to include a statewide mask mandate for people, vaccinated or unvaccinated, in indoor public spaces.

The mandate will apply to everyone 5 and over and will take effect Wednesday. It will be in effect until Sept. 1.

The mandate will apply to schools, Edwards said. The St. Mary Parish School Board had voted July 8 to recommend but not require masks for students and employees. The 2021-22 school year begins here Friday.

The move comes after the governor and State Health Officer Dr. Joseph Kanter said Friday that COVID hospitalizations in Louisiana are at seven times the level they were a month ago, and that a key measure of new COVID cases per capita is 900% of what it was in early July.

More than 13% of recent COVID tests have returned positive results.

Louisiana Attorney General Jeff Landry is opposing vaccine mandates at in-state colleges and universities, saying they violate student rights.
Landry sent a letter this week to Edward Via College of Osteopathic Medicine, located at the University of Louisiana-Monroe, warning of a possible lawsuit if the college doesn’t amend its vaccination policy.
“As I have previously stated, I intend to pursue legal action to protect the rights of Louisiana residents attending VCOM who have declared their objections to the coercive mandate to be vaccinated with an EU-approved [Emergency Use] vaccine,” he said.
Landry maintains that vaccine mandates violate state and federal law. He approached the college’s administration after several students said they were retaliated against for refusing to get vaccinated.
“These complaints have included recordings of conversations with VCOM staff engaging in harassing and coercive conduct targeting students who have exercised their right to opt-out of receiving a COVID-19 vaccine,” he said.
The medical school disputes the attorney general’s characterization of events and says it has acted in accordance with the school’s health and legal obligations.
“The intention of VCOM’s coronavirus vaccine policy, is and always has been the safety of our students, the safety of our employees and workplace, as well as the safety of the patients being cared for by our students, faculty and staff,” VCOM said in a statement.
“Unfortunately, the policy was not accurately described in the letter, which was the first communication VCOM received from the Attorney General’s office,” the statement said. “From the beginning, VCOM has committed to remain compliant with the laws of Louisiana.”
The school explained that all but three of its 300 students are vaccinated, and that it offers an exemption process for mandatory vaccines.
“The avenue to request a medical, religious, or judicially approved exemption to the policy has been made available to those students,” VCOM said, adding that dissenting students could also defer admission until the next academic year when COVID-19 vaccines are expected to be fully approved by government health agencies.
In his letter, Landry said the school’s exemption process was “structured to deny waivers.”
“VCOM has threatened the students with costly delay or abandoning of their medical education, which is clearly intended to coerce them into being vaccinated and is not necessary to protect public health. By focusing on the small number of known students who have vigorously objected, you are missing the point that the law protects this minority view,” he wrote.
Complicating matters is the school’s partnership arrangement with the University of Louisiana-Monroe, a taxpayer-funded public school. VCOM is a Virginia-based private entity with satellite medical schools in several states, including Louisiana. It occupies space at ULM and works with the university but is not part of it.
University of Louisiana System President Jim Henderson has said VCOM is separate from the state higher education system and is therefore free from the attorney general’s claims. Landry disagrees.
The clash may serve as an indication of future events regarding Louisiana State University and its 34,000 students, the most of any higher education institution in the state.
The LSU faculty voted for mandatory student vaccines at the close of the spring semester, but a mandate has not yet been implemented.
A faculty resolution cites Duke, Rutgers, Notre Dame, Brown and Cornell universities as all requiring student vaccines as a condition of in-person attendance for fall 2021. The approach would entail updating LSU’s existing immunization policy covering measles, mumps, rubella, tetanus, diphtheria and meningococcus.
“The LSU Faculty Senate requests that PS–72 be revised to require COVID-19 vaccinations for all eligible students wishing to enroll in in-person classes or other events on campus or implement a similar requirement via another administrative policy or procedure,” the resolution reads.
Landry confronted LSU’s then-interim President Thomas Galligan and asserted state university employees and students are protected against mandated coronavirus vaccines because the U.S. Food and Drug Administration has not officially approved them.
The FDA is streamlining its vaccine approval process though it’s unlikely a finalized approval will come prior to LSU’s fall semester, which begins Aug. 9. ULM’s fall semester begins Aug. 16.
Landry gave VCOM until Friday, July 30, to respond to concerns outlined in his recent letter.
“It is my understanding that VCOM has advised it will determine whether the students’ objections meet VCOM’s standards sometime in the next two weeks. I would like to have an answer by close of business Friday or I will join in seeking legal protection for the students,” he said.