News

Carmell Therapeutics Gains Alignment with FDA on a Path Forward to Evaluate the Use of Its Lead Product, a Bone Healing Accelerant, in Foot and Ankle Fusion Surgery

Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, announced that it has gained alignment with U.S. Food and Drug Administration (FDA) on requirements for the evaluation of the Company’s lead product, a Bone Healing Accelerant (BHA) in a second indication, foot and ankle fusion surgery.

Carmell Therapeutics Announces the Appointment of Sebastian “Sebby” Borriello to Chief Business Officer

Carmell Therapeutics, a pioneering company in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, today announced that Sebastian “Sebby” Borriello joined the company as Chief Business Officer.

Carmell Therapeutics Announces Appointment of Dr. Israel Nur as Scientific Advisor

Carmell Therapeutics, a pioneering company in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, today announced that Dr. Israel Nur joined the company as a Scientific Advisor.

FDA grants Carmell Therapeutics Expedited Review for CT-101, Bone Healing Accelerant

Carmell to begin enrolling in pivotal clinical program for first-of-its-kind Plasma-based Bioactive Material product used in long-bone fractures as an adjunctive treatment.

Congratulations to Carmell Therapeutics on being selected as an Innovation Leader at LSI’s Emerging Medtech Summit 2020

Carmell Therapeutics Receives IND Clearance for CT-101, Bone Healing Accelerant

Carmell to begin enrolling in pivotal clinical program for first-of-its-kind Plasma-based Bioactive Material product used in long-bone fractures as an adjunctive treatment.

Startup Spotlight: Carmell Therapeutics Takes Regenerative Medicine to the Next Level with Controlled Degradable Biologic

When someone cuts herself and starts to bleed, her platelets aggregate to stop the bleeding. Over time, the body’s enzymes will break down that clot, providing the body’s stem cells with the regenerative factors naturally contained in platelets and plasma.

Pursuing a Path of Regulatory Rigor: Taking Medtech, Regenerative Medicine to the Next Level

The medical device industry is facing a generational change in the regulation and validation of its products.

The Path to be First — How Carmell Therapeutics Could Have the 1st BLA-Certified Regenerative Offering for Bone Healing

Biologics therapies have the promise to revolutionize orthopedics and sports medicine, but unauthorized operators pose a serious threat to emerging therapies.

Toward A More Robust Regenerative Medicine Regulatory Pathway

In recent months, the U.S. Food and Drug Administration has increased its compliance focus on the regenerative medicine industry, vowing to crack down on illicit stem cell clinics and others advertising the untested use of human cell and tissue-based products (HCT/P), many of which are used in orthopedics.