Mainstay Medical launches limited commercial launch of the neurostimulation system in the United States

August 26, 2021

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Disclosure:
Bruder reports as a paid consultant for Aesculap / B.Braun, Alma Lasers, Anika Therapeutics, Arthrex Inc., Axogen, Celularity, Collagen Matrix Inc., Conventus Flower Orthopedics, Cook Biotech, Elite Regenerative Institute, Histogen, Kolon Tissue Gene, Lipogems, MTF Biologics, Navadip Bioscienes, Personal Stem Cells, Regeneus Ltd., RTI Surgical, Sparta Biopharma, and Terumo BCT; as an employee of Bruder Consulting & Venture Group LLC; Have stocks or stock options on Lipogeme; and be a board member or committee member for AAOS. Halbrecht reports being a paid consultant for Lipogems.

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Clinicians must be aware of the contents of the FDA’s June 3 memo regarding the use of human cell and tissue products and be aware that the guidance issued on November 15, 2017, has not changed, according to a regulatory adviser.

Scott Brother, MD, PhD, who works with companies to bring new drugs, devices, biologics, and combination products through the FDA approval process, discussed the June 3 memo “Important patient and consumer information on therapies with regenerative medicine”. He informed Healio Orthopedics that the purpose of the memo, which was addressed to patients and consumers, was to be used on the 31st for the development and monitoring of regenerative medicine products, including novel cell therapies, “approved in November 2017 by the then FDA Commissioner Scott Gottlieb, MD released.

The June 3 memo did not contain any new or updated rules, Brother said.

Scott brother

Scott brother

According to the June 3 memo, “[Unapproved] Products require FDA license / approval to be marketed to consumers. Before approval, these products must be supervised by the FDA in a clinical study. These unapproved products include stem cells, stromal vascular fraction (fat cells), cord blood and / or cord blood stem cells, amniotic fluid, Wharton jelly, orthobiologics and exosomes. The FDA has received reports of blindness, tumor formation, infection, and more due to the use of these unapproved products, which are listed below. “

Prohibited use

Some human cell and tissue (HCT / Ps) products were able to find an upcoming book called “Orthobiologics: Scientific and Clinical Solutions for Orthopedic Surgeons” before the 31st.

“Stem cell products are not approved for orthopedic diseases,” he said.

Regarding certain other products, orthopedic surgeon Joanne Half right, MD, FAAOS, Healio Orthopedics said, “If you look at the current manual, you will find that it was never legal. Doctors need to know about the regulations. You also need to educate yourself on safety and effectiveness. “

The caveat is that these products will be used by a doctor in an appropriately registered clinical trial as part of the FDA approval process and study participants will not pay for treatment with the products within the boundaries of the study, Brother said.

Joanne Halbrech,

Joanne Half right

When the initial guidance was announced, the end date of the enforcement discretionary period for certain biologics was November 2020, “exactly 36 months after the 2017 announcement To move studies forward, they opted for a six-month extension, ”Brother said. Hence the memo of June 3, which reminds of the end of the discretionary period on May 31, 2021.

Brother, who has been giving seminars, lectures and webinars on this topic since November 2017, said: “I and others have given presentations at various specialist conferences and in publications, and the agency has made this clear. Anyone who works in this area shouldn’t be surprised at the June 3rd memo. “

At the first opportunity he had in person, Brother spoke about the FDA memo of the 3rd, in Nashville, Tennessee.

“As I discussed at the Nashville event, there is nothing new. It’s just a repetition of the 2017 rules, ”Brother said.

He lectured on the subject at the Vail Scientific Summit August 19-22 in Vail, Colorado, and will do the same at the AAOS Annual Meeting in San Diego during a seminar talk on September 2nd, moderated by Halbrecht.

Halbrecht said she recently spoke on the subject at the MSK Ultrasound and Orthobiology course from July 29th to 31st in Las Vegas, where she told attendees, “Basically, you can’t use allogeneic products from the list that im FDA Memo of June 3. You can be assured that you are using FDA-cleared equipment to produce autologous HCT / Ps, but if the HCT / P is used in an off-label indication, you must oppose that clinical use justify the patient and obtain appropriate consent. “

Execution Period

What came to an end on May 31 was the FDA’s discretionary decision, during which the FDA turned its attention to the companies and doctors selling unapproved HCT / Ps with the highest risk profile, Brother said.

“That means the FDA has taken a risk-based approach to enforcement actions like issuing warnings or untitled letters. During that time, that didn’t mean everyone got a free pass. That meant the agency was watching and tracking those who appeared to be participating in activities with the highest risk, ”Brother said.

Brother stated that in the period from November 2017 to May 31, 2021, the FDA cited companies that offer stem cell products that are injected into the eye or spinal cord, for example, because these are considered high-risk procedures.

In comparison, injecting micronized amniotic membrane into the knee to treat osteoarthritis, while still an unapproved product, has not been the subject of significant enforcement action by the FDA, he said.

“You haven’t aggressively pursued companies like MiMedx Group that sold such products, even though the guidelines said you had one [biologic license approval] BLA for that. Companies like this waited to see, “Well, should I keep marketing this after May 31st? Will the authorities give me a free pass while I get a permit? ‘ And the answer to that is no, ”said brother. MiMedx is currently running several FDA-registered studies to meet regulatory requirements for its micronized amnion products, Brother noted.

According to the FDA memo, “Regenerative medicine therapies are not approved for the treatment of orthopedic conditions such as osteoarthritis, tendinitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain. ”

Brother said, “An important tenet is that doctors understand that they can use any product that has a reasonable legal basis for commercial availability, however, based on their clinical judgment, they can use the same way that they use medicines prescribe outside the label; that’s called medicine. What they are not allowed to do is sell or supply products to patients who have no basis for legal commercialization. And there are many because of the bad behavior of certain companies who resell their counterfeit or mislabeled products without proper government approval. There is a list of such products in this June 3 memo, including amniotic fluid, Wharton jelly, micronized amniotic fluid membrane, or anything called a “stem cell.” There are no products approved for stem cells for orthopedics. Period. So do not market, advertise, or advertise that you are doing anything with stem cells to treat your patients, as this will be considered false advertising by them [Federal Trade Commission] FTC and serves as a beacon for the FDA to contact you and not with good news. The FDA says it has sent out approximately 400 enforcement letters to sponsors and doctors in the past 3 years, “Brother said.

According to Halbrecht: “If you want to use biologics ethically and legally and use and market them appropriately for your patients, you must comply with the regulations of the FDA and the FTC as well as the published research results. There are examples where clinics and doctors have suffered multi-million dollar fines and loss of medical license for violating these regulations. “

She suggested that doctors list some relevant studies on their website and let patients read those studies and then decide for themselves whether to continue treatment.

The way doctors use and market HCT / Ps and orthobiologics must be scientifically proven and ethical, Halbrecht said.

“The best way to help patients and make them feel better is by offering them safe, effective products and making them feel good about marketing. We want to be on the cutting edge of technology. Biologics are the future of orthopedic medicine. It’s great to be able to offer our patients an alternative to surgery, ”says Halbrecht.

References:

Kingery MT et al. J Bone Joint Surgery Am. 2020; doi: 10.2106 / JBJS.19.00714.

www.fda.gov/media/109176/download

www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regenerative-medicine-policy-framework

www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/questions-and-answers-regarding-end-compliance-and-enforcement-policy-certain-human-cells-tissues-or

www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies

www.healio.com/news/orthopedics/20210708/speaker-be-compliant-with-fda-bilogic-product-regulations-to-stay-out-of-trouble

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