Startups

Following some big FDA wins, Carmell Therapeutics plans to go public. Here’s why

"What we're doing is a big vision," CEO and President Randy Hubbell said. "It could fundamentally change the way tissue is healed and regrows after disease, injury and aging."

Carmell Therapeutics CEO Randy Hubbell.

(Courtesy photo)

Life sciences company Carmell Therapeutics started September by taking the first steps toward going public: filing a draft registration statement with the US Securities and Exchange Commission for a public stock listing.

CEO and President Randy Hubbell told Technical.ly that taking the company public primes the Carmell Therapeutics’ products for commercialization. Currently in the clinical development stage, the South Side-based startup has investors, but no revenue. So when the company has finished with its clinical trials and been listed on the Nasdaq — it’s aiming for Q4 2022 or early 2023 — Hubbell says the company will be able to show the value of its products and positively impact future sales.

Why follow the 2021 steps of fellow Pittsburgh companies Duolingo, Stronghold Digital Mining, Aurora and Cognition Therapeutics and go public?

“We believe that the better place to be is in the public markets where we can attract capital, because we look a lot like a biotech company,” Hubbell said. “Biotech companies have had success in the public markets by creating value for their investors by successfully advancing through the clinical regulatory pathway and bringing forth significant clinical data.”

Randy Hubbell. (Courtesy photo)

The products Carmell Therapeutics would like to advance focus on regenerative medicine, including for tissue, hair, skin, bones after injury, disease or aging. Recently the company has completed Phase 2 of a study showing its Bone Healing Accelerant which has the ability to (as you might have guessed) accelerate and heal bone and soft tissue damage. The second product it’s been preparing is its Tissue Healing Accelerant which focuses on chronic wound healing and hair regrowth for individuals with alopecia.

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“All of those applications are very large total available markets, and all of them have significant unmet needs,” Hubbell said. “Our technology has promise of working to regrow those tissues because the base technology is very well understood and the science is very well known.”

The Carnegie Mellon University spinout develops its technology by using allogeneic plasma, which contains significant growth factors and regenerative factors that are an important part of regrowing tissue. Hubbell explained that recently the company had obtained the Investigational New Drug clearance from the US Food and Drug Administration, meaning it has the green light to conduct clinical testing of the Bone Healing Accelerant. Additionally, the FDA has granted the company’s technology an expedited review, a process meant to get important drugs to patients faster.

“That suggests that they see that there is a significant unmet need without the necessary technology to address and they believe our technology would help meet that medical unmet need in tibia fractures,” Hubbell said. “What we’re doing is a big vision. It could fundamentally change the way tissue is healed and regrows after disease, injury and aging.”

Carmell Therapeutics HQ. (Courtesy photo)

With plans to go public and clinical trials progressing, Hubbell said the company — currently comprising 15 employees, nine of which are Pittsburgh based — is set to expand by doubling its staff and possibly expanding its building to accommodate manufacturing when the time for commercialization comes. Still, even as the company grows larger with more researchers and finance staff, Hubbell insists Carmell Therapeutics is committed to continuing to call Pittsburgh home.

“We’re fully committed to Pittsburgh, we’re fully committed to the River Park Commons facility,” the CEO said of Carmell’s HQ. “We have no, no plans on leaving the Pittsburgh area or South Side.”


Atiya Irvin-Mitchell is a 2022-2023 corps member for Report for America, an initiative of The Groundtruth Project that pairs young journalists with local newsrooms. This position is supportedby the Heinz Endowments. -30-
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