Participation Limited to Verified Accredited Investors
Lionheart Health, Inc. announces that it has filed a Form D with the U.S. Securities and Exchange Commission in connection with an offering seeking to raise up to $3 million in reliance on Rule 506(c) of Regulation D.
Only verified accredited investors may invest, preferably with early biotech or medtech startup investment experience. The Company will take reasonable steps to verify each purchaser’s accredited investor status before accepting an investment.
Company Focus
The Company is focused on applying patented and patent-pending bioelectric controlled protein expressions, including bioelectrically enhanced biologics, toward:
- Regenerative aesthetics
- Healthspan longevity, including organ regeneration and recovery
- Animal treatments, via subsidiary Lionheart VetStim (www.lionheartvetstim.com)
- Bioelectric and Klotho-based cancer treatment
All via a single focused platform technology: bioelectric control of protein expressions on demand.
Lionheart Health is an early-stage biotechnology and medical technology company developing systems intended to support whole-body and multi-organ regeneration. These ambitious research and development objectives remain experimental. The Company has not established that its proposed systems can achieve whole-body or multi-organ regeneration at commercial scale, and there is no assurance that these objectives will be achieved.
THIS IS A HIGH-RISK, SPECULATIVE INVESTMENT. INVESTORS COULD LOSE THEIR ENTIRE INVESTMENT. Risks include scientific and clinical failure; regulatory delays, potentially highly lengthy and maybe even decades, or denial; enormous commercialization challenges; substantial additional financing needs, which may not be secured; dilution; and illiquidity. Investors must be able to bear a complete loss and hold their investment for an indefinite period.
Regulatory Status
Lionheart Health reports that SkinStim™, HairCell™, OrthoStim™, BodStim™ and ErectiStim™ are commercially available with proper marketing labeling only (such as for improving circulation) through OEM manufacturer partners using devices with existing FDA 510(k) clearances. Depending on the specific device and its cleared labeling, the Company’s regulatory advisors have identified indications involving muscle building and recovery, improved circulation, pain relief—including certain inflammation-related and arthritis or osteoarthritis pain—postoperative blood clot prevention, enhancement of exercise-related muscle conditioning, and certain rehabilitation uses following stroke. These indications do not apply uniformly to every product and do not establish standalone FDA clearance for skin or hair regeneration, sexual health, whole-body regeneration, reduced exercise time or other investigational claims unless expressly supported by the applicable device’s cleared labeling, such as improving circulation, muscle building or recovery, pain relief or arthritis pain treatment. Although the Company’s regulatory advisors believe a conservative commercialization pathway exists within documented cleared indications, FDA may disagree with the Company’s interpretation or determine that particular products, modifications, labeling or uses require additional clearance or approval.
The Company also reports IRB approval of a controlled clinical study evaluating investigational regenerative applications of bioelectric stimulation, with informed patient consent and independent Data Safety Monitoring Board oversight, under an IRB determination that the study involves a nonsignificant-risk device. This determination applies to the approved study and does not constitute FDA clearance or approval of regenerative therapies. FDA may disagree with the risk determination for some or all studied uses and require an approved Investigational Device Exemption or other regulatory action before those investigations may proceed or continue, potentially resulting in delays, additional costs, study suspension or limitations on commercialization.
Requesting the Private Placement Memorandum
To request the Private Placement Memorandum, including the complete Risk Factors section and offering terms, email CS@lionheartlongevity.com. Prospective investors should review the entire PPM and related offering documents and consult their own legal, tax and financial advisers before investing. The risks summarized in this announcement are not exhaustive.
The securities have not been registered under the Securities Act of 1933 or applicable state securities laws and will be subject to restrictions on transfer and resale. Filing a Form D does not constitute SEC approval, registration or endorsement. Neither the SEC nor any state securities regulator has approved or disapproved the securities or determined the accuracy or completeness of the offering materials.
“Lionheart Health has an encouraging opportunity to build a sustainable business around health optimization and bioelectric technologies. Our financial priorities are disciplined spending, responsible capital allocation and measurable commercial progress. While growth will require careful execution, we are optimistic about the company’s potential to create long-term value.”
— Scott Jordan, Chief Financial Officer, Lionheart Health, Inc.
Any investment will be subject to the PPM, definitive subscription documents, verification requirements and applicable law. No offer or sale will be made where unlawful. Statements concerning future development, clinical outcomes, regulatory approvals or commercialization reflect current expectations and involve substantial uncertainties; actual results may differ materially.
Lionheart Octopus™ — grant-supported deep organ regeneration technology platform in research phase, covered by over 100 patent claims.
Additional Disclaimers
Patents issued may be invalidated. Patents pending may not be issued. Patents in process may not be fully filed and issued. Patents may expire due to failure to pay maintenance fees. The Company may be found to be infringing patents of others. Licensed and optioned patents are subject to multiple ongoing conditions which may not be met, and thus licenses and options may expire. Early clinical data may not translate to larger-scale positive clinical results or commercialization success. Animal and other pre-clinical data may not translate to clinical or commercial success. The team lacks resources to bring all products in the pipeline through clinical trials and onto commercialization launch. The Company will likely have to raise substantially more capital going forward, which will dilute early investors’ holdings. Patients may sue the Company for product liability issues, and the Company may lack sufficient insurance protection. The Company works with a very small staff relative to peer group companies and may not have adequate personnel to handle important duties necessary for commercial success and investor return. The Company may fail to raise the capital needed to finish clinical studies and commercial launches with a proper marketing budget. Many advisor, employee, partnership, contractor and supplier agreements need to be formalized, renewed or extended.
The Company has not yet completed full-scale CPA GAAP-compliant audits of two years of its financials, and there could be, despite the honest good intentions of management, some inaccuracies in detailed financial information. The Company cap table and Blue Sky reporting are under current external review to determine if any cleanup is needed and if any filings need to be made. Early review has determined some Blue Sky filings now have to be made late and are on schedule to be made in the next weeks to bring the Company into full compliance. The Company also has to file an updated Annual Report with the State of California. To the best of our knowledge, income tax returns are up to date but are subject to review. A review of compliance with state sales tax laws is underway, and whether we are in full compliance is undetermined as of this date.
Important Securities Notice: This announcement is provided for informational purposes and does not contain all information necessary to evaluate an investment in Lionheart Health, Inc. Any offer or sale of securities will be made only through the Company’s Private Placement Memorandum and definitive offering documents, subject to applicable law, verification of accredited investor status and acceptance by the Company. No offer or solicitation is made in any jurisdiction where it would be unlawful. The securities have not been registered under federal or state securities laws and are subject to restrictions on transfer and resale. Filing a Form D does not constitute SEC approval or endorsement of the Company or the offering. An investment is speculative, involves substantial risk and may result in the loss of the entire investment.
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