Newsletter: BOOM, Boosters, and Pigney Transplants | October 25th, 2021View All articles
BOOM, Boosters, and Pigney Transplants
Hope you had a good weekend.
Did you hear? Healthcare is BOOMING. Reaching nearly $40B in total funding in 2021 so far. New deal count record went up 15% from last Q.
In 2020, the MedTech market grew 6.3%, and 94% of Medtech companies are already reporting a stronger 2021 than 2020.
After the uncertainty of the pandemic’s effects, 2022 is looking promising.
Dolphin (Video Game) Therapy
The rise of digital therapeutics has been hard to miss and because of that it’s been a hotbed for SPAC deals recently. See Pear Therapeutics.
And companies like MindMaze are pushing the envelope on video game therapy and its effects on stimulating brain recovery. The digital therapeutics developer is helping users rehabilitate neurological damage from stroke, Parkinson’s Disease, and other brain conditions by combining physical therapy and virtual gaming.
In the rehabilitation game, MindPod Dolphin, patients wear an anti-gravity vest to “de-weight” the stroke affected arm. The arm is then place inside a robotic sleeve that enables the exploration of movement and the tuning of fine motor control through the fluid movements of a dolphin maneuvering an oceanic world.
With financial backing from Leonardo DiCaprio and multiple $100 million-plus funding rounds and FDA and CE clearances, MindMaze is making its way through the labyrinth of going public.
But it doesn’t stop there for MindMaze. The possibilities of the pairing of these digital therapeutics with drugs could reshape this type of patient care completely.
“One avenue to pursue will be to partner with pharmaceutical companies to promote brain repair by combining our digital therapeutic neurorestorative approach with emerging drug discovery,” MindMaze CEO and Founder, Tej Tadi Ph.D., stated."
Return of the Jab
On Wednesday, the FDA released an update on the state of booster doses for the Covid-19 vaccine.
Back in September, the FDA recommended booster shots of the Pfizer/BioNTech Covid-19 vaccine for adults 65 and over, high-risk individuals, and adults with frequent exposure to Covid-19 through work. These were only for people who had previously received the Pfizer vaccine.
Wednesday’s update now opens the door for Moderna and J&J recipients.
For Moderna, The FDA gave emergency use authorization for a half dose of Moderna's vaccine as a booster for people fully vaccinated at least six months ago, who also met the same restrictions given for the Pfizer vaccine mentioned above.
As for J&J, the FDA signed off on boosters of Johnson & Johnson’s vaccine for anyone who received it at least two months ago.
One of the most interesting tidbits to come out of the FDA’s announcement is the approval of a heterologous or a "mix-and-match" approach to boosters.
Here’s what the FDA had to say on mix-and-match:
“For example, Janssen COVID-19 Vaccine recipients 18 years of age and older may receive a single booster dose of Janssen COVID-19 Vaccine, Moderna COVID-19 Vaccine (half dose) or Pfizer-BioNTech COVID-19 Vaccine at least two months after receiving their Janssen COVID-19 Vaccine primary vaccination."
“In another example, Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 vaccine recipients falling into one of the authorized categories for boosters (65 years of age and older, 18 through 64 years of age at high-risk of severe COVID-19, and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2) may receive a booster dose of Moderna COVID-19 Vaccine (half dose), Pfizer-BioNTech COVID-19 Vaccine or Janssen COVID-19 Vaccine at least six months after completing their primary vaccination.”
Pigney Transplant Success
In what sounds like a story out of Ripley’s Believe or Not— surgeons at N.Y.U. Langone Transplant Institute have successfully attached a kidney grown in a genetically-altered pig to a human patient without any complication or rejection.
In the first operation of its kind, surgeons attached the pig’s kidney to a brain-dead patient sustained on a ventilator. Doctors monitored the body’s response, as well as the kidney’s function for 54 hours, noting normal levels of urine and creatine.
“There didn’t seem to be any kind of incompatibility between the pig kidney and the human that would make it not work. There wasn’t immediate rejection of the kidney,” said Dr. Robert Montgomery, the director of the N.Y.U. Langone Transplant Institute, who performed the procedure.
Though deemed a success, don’t expect the pig-organ-harvesting industry to pick up just yet. There is still much work to be done, including peer-reviewed studies.
But as you may have guessed PETA’s stance on the topic. Saw that one coming.
What do you think? With a shortage of organs available for surgeries, should pigs fill the void?
Drop us a line and let us know what you think.
Knowledge Base Highlights:
New Webinar Recording Alert! Learn the Benefits of a Well-Developed Regulatory Plan from our Director of Regulatory Affairs, Isabella Schmitt. Listen here.
What to learn the FDA's Good Clinical Practice (GCP) requirements for data submitted from clinical Investigations for In Vitro Diagnostic (IVD) device premarket submissions.
This knowledge applies to all clinical investigations of devices involving human subjects, including deidentified human
Read more here.