Carmell™ Therapeutics expands manufacturing capabilities to support Phase III clinical trials

May 9, 2017

Carmell Therapeutics recently held a productive pre-IND meeting with the FDA, significantly advancing the company’s clinical and regulatory strategies and driving the company’s need to expand its manufacturing facilities.

Carmell, a biotechnology company focused on the development and commercialization of regenerative medicine technologies, will soon be conducting a Phase III clinical study for its first product/indication, Bone Healing Accelerant. This will be the first of many products and indications based on its core Plasma-based Bioactive Material (PBM) technology. The PBM technology was developed at Carnegie Mellon University and utilizes pooled plasma to create products which accelerate the healing of both bone and soft tissues. A unique benefit of this patented technology is its ability to control the breakdown of PBM in the body, releasing a broad range of growth and healing factors over different periods of time when the body needs them most to accelerate healing.

To expedite commercialization, Carmell has secured a site for its new, state-of-the-art manufacturing facility. Carmell will move its headquarters, including the R&D lab and manufacturing capacity, to a new facility located at 2403 Sidney Street Pittsburgh, PA on May 22, 2017. “Designing the manufacturing site to fit our specific product needs and now being able to include product manufactured at our new facility in the clinical trial will allow for a seamless regulatory submission to the US FDA, EMA and other regulatory bodies around the world,” commented Randy Hubbell, President & CEO of Carmell.

Plasma-based Bioactive Materials – Using the Body to Heal Itself

Carmell is a biotechnology company focused on the development and commercialization of regenerative medicine technologies. Founded as a spin out from Carnegie Mellon University in Pittsburgh, PA, Carmell Therapeutics has created a unique and highly innovative patented technology based on biologically-active materials manufactured from human blood plasma. These Plasma-based Bioactive Materials (PBMs) contain a concentration of natural regenerative factors that promote healing in various clinical settings, reduce infections, reduce complications, and, as a result, save healthcare costs. Unlike previous approaches to delivering growth factors to injuries/surgeries, Carmell has patented the capability to achieve three important technological breakthroughs: form, presence and bioactivity.

  1. The regenerative materials can be manufactured to fit multiple forms, such as putties, pastes, scaffolds, plugs, screws and sheets.
  2. Presence is created by cross-linking the proteins as part of the manufacturing process and thus controlling the breakdown in the body over different periods of time (days, weeks or months).
  3. As the regenerative biomaterial (PBM) biodegrades at the local site, active biologics are released where and when the body needs them to accelerate healing.

Carmell’s first PBM product, Bone Healing Accelerant, has been designed to treat bone fractures, through accelerating bone healing of the fracture and surrounding soft tissues while reducing complications, infections and duration of care.

For more information on Carmell Therapeutics, please visit the Company's website at http://www.carmellrx.com/

Some of the statements in this release are “forward looking statements,” which involve known and unknown risks and uncertainties.  These statements are only predictions.  Carmell makes no representation, warranty or claim regarding its products or any information in this release. Actual results may vary significantly from our predictions and depend on known and unknown factors, including, without limitation, the outcome of our plans to conduct additional human clinical studies to prove the safety and efficacy of our products.

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