H-CYTE Completes Acquisition of SkinDisc™ Regenerative Tissue Kit from Scion Solutions, LLC

Rhea-AI Summary

H-CYTE, Inc. (OTCQB: HCYT) has completed the acquisition of SkinDisc™, enhancing its asset portfolio in the wound healing and limb salvage market. SkinDisc™ shows promising early clinical outcomes, achieving healing in 4-9 weeks compared to traditional methods which can take 12-20 weeks. With over 500 patients treated, H-CYTE plans to submit a De Novo 510(k) pathway request in the first half of 2023. This acquisition positions H-CYTE to tap into a $2 billion market, demonstrating its commitment to next-generation cellular therapeutics.

Positive

• Acquisition of SkinDisc™ diversifies H-CYTE's product portfolio.
• SkinDisc™ has shown significant early clinical outcomes in wound healing.
• The product achieves faster healing times (4-9 weeks) compared to standard treatments (12-20 weeks).
• H-CYTE plans to submit a De Novo 510(k) request in the first half of 2023.
• The total addressable market for wound healing is estimated at $2 billion.

Negative

• The acquisition was funded through equity proceeds, potentially causing shareholder dilution.

Wound Healing and Limb Salvage Technology Added to Growing Asset Portfolio
Company’s Second Completed Transaction in Four Months

TAMPA, Fla., Dec. 29, 2022 (GLOBE NEWSWIRE) -- H-CYTE, Inc. (OTCQB: HCYT), a medical biosciences company, announced today that the Company completed its acquisition of SkinDisc™.

Highlights:

• SkinDisc™ acquisition further diversifies H-CYTE’s asset portfolio
• Early clinical outcomes of SkinDisc™ application demonstrated significant results relative to current treatment options in wound healing and limb salvage
• Currently in dialogue with the FDA and have a manufacturer established
• Over 500 patients treated with SkinDisc™ to date
• Single application can achieve healing in 4-9 weeks
• H-CYTE will submit a De Novo 510(k) pathway request for SkinDisc™ in the first half of 2023
• Equity proceeds funded the acquisition of SkinDisc™
  

“The completed acquisition of SkinDisc™ marks a pivotal moment for the Company, representing our second closing of a potentially life-saving technology asset under development in the past four months,” said Michael Yurkowsky, H-CYTE’s Chief Executive Officer. “Acquiring a proprietary technology like SkinDisc™ highlights our ability to add attractive assets to our product portfolio as we evolve into a leading hybrid biopharmaceutical company. The H-CYTE team is excited to enter the wound healing and limb salvage space, which has a $2 billion total addressable market opportunity. SkinDisc™ will position the Company to combat the rising prevalence of acute, chronic, and surgical wounds with an effective and affordable treatment. We expect to submit a De Novo 510(k) pathway request for SkinDisc™ in the first half of 2023.”

From a single application, SkinDisc™ provides an active cellular matrix that maintains complete full wound contact and depth fill during the healing process, resulting in rapid growth of the host tissue. The SkinDisc™ product achieves healing in four to nine weeks, compared to current treatment approaches that require weekly applications and can take 12-20 weeks to heal, on average.

About H-CYTE, Inc.

H-CYTE is a medical biosciences company. H-CYTE’s mission is to become a leader in next-generation, cellular therapeutics for the treatment of chronic health conditions, with the ultimate goal of improving patient lives. For more information about H-CYTE, please visit www.HCYTE.com.

Safe Harbor Statement

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While H-CYTE believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those outlined in H-CYTE’s filings with the SEC, including but not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. H-CYTE expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

H-CYTE Investor Contact:

Alpha IR Group
HCYT@alpha-ir.com
312-445-2870

Source: H-CYTE, Inc.

FAQ

What is the significance of H-CYTE's acquisition of SkinDisc™?

The acquisition diversifies H-CYTE's asset portfolio and positions it in a growing market for wound healing.

What are the early clinical results for SkinDisc™?

Early results indicate that SkinDisc™ can achieve healing in 4-9 weeks, significantly faster than current treatments.

What is H-CYTE's plan after acquiring SkinDisc™?

H-CYTE plans to submit a De Novo 510(k) pathway request for SkinDisc™ in the first half of 2023.

How many patients have been treated with SkinDisc™ so far?

Over 500 patients have been treated with SkinDisc™ to date.

What is the market opportunity for SkinDisc™?

The total addressable market for wound healing and limb salvage is estimated to be around $2 billion.