H-CYTE Announces Intent to Acquire SkinDisc, Expects to Complete Within 30 Days

Rhea-AI Summary

H-CYTE, Inc. (OTCQB: HCYT) announced a letter of intent to acquire SkinDisc, a patent pending tissue regeneration technology, expected to close within 30 days. This acquisition aligns with H-CYTE's vision to build a diverse asset portfolio and transition into a hybrid-biopharmaceutical company. SkinDisc has shown early clinical success, treating 250 patients with healing achieved in 4-9 weeks, significantly faster than traditional methods. H-CYTE plans to submit a De Novo 510(k) request for SkinDisc by mid-2023, addressing a market opportunity worth $2 billion.

Positive

• Acquisition of SkinDisc strengthens H-CYTE's asset portfolio.
• Significant clinical outcomes from SkinDisc could improve patient care in wound healing.
• SkinDisc offers healing in 4-9 weeks, outperforming current treatment options.

Negative

• None.

Wound Healing and Limb Salvaging Technology Adds to Company’s Asset Portfolio Focused on Unmet Medical Needs

TAMPA, Fla., Sept. 19, 2022 (GLOBE NEWSWIRE) -- H-CYTE, Inc. (OTCQB: HCYT), a medical biosciences company, announced today that the Company has entered into a letter of intent to acquire SkinDisc, a patent pending tissue regeneration technology, that is expected to close within the next 30 days.

Highlights:

• Further supports H-CYTE’s vision to build a diverse asset portfolio and transform into a hybrid-biopharmaceutical Company
• Early clinical outcomes of SkinDisc application demonstrated significant results relative to current treatment options in wound healing and limb salvaging
• 250 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
  

“The acquisition of SkinDisc represents another significant addition to our portfolio of potentially life-saving technologies under development,” said Michael Yurkowsky, H-CYTE’s Chief Executive Officer. “With the rising prevalence of acute, chronic, and surgical wounds over the last decade, and a total addressable market opportunity of $2 billion, the H-CYTE team is excited to help foster affordable treatments for those in need of wound care and limb salvaging. To best serve those who can benefit from this proprietary technology, the Company plans to work with surgeons, podiatrists, and physicians to treat patients with severe trauma-based wounds and non-healing chronic wounds.”

SkinDisc maintains complete full wound contact and depth filling during the healing process, resulting in rapid growth of the host tissue from an active cellular matrix in a single application. The SkinDisc product has achieved 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 acquisition of SkinDisc by HCYT?

H-CYTE is acquiring SkinDisc, a patent pending tissue regeneration technology, to enhance its asset portfolio and address unmet medical needs in wound healing.

When is the SkinDisc acquisition expected to close?

The acquisition of SkinDisc is expected to close within the next 30 days from the announcement on September 19, 2022.

What are the potential benefits of SkinDisc?

SkinDisc has demonstrated the ability to heal wounds in 4-9 weeks, providing a significant improvement over traditional methods that can take 12-20 weeks.

What is the market opportunity for HCYT with SkinDisc?

The total addressable market opportunity for wound care treatments, including SkinDisc, is estimated to be worth $2 billion.

When will HCYT submit the De Novo 510(k) request for SkinDisc?

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