SMTI Sanara MedTech Inc.

Risks

• We had a history of losses in prior years and may not maintain profitability as we expand our selling efforts.
• Our revenue growth for a particular period is difficult to predict, and a shortfall in forecast revenues may harm our operating results.
• If our products do not gain market acceptance, we might not be able to fund future operations.
• Disruption of, or changes in, our distribution model or customer base could harm our sales and margins.
• If we cannot meet our future capital requirements, our business will suffer.
• Failure to retain and recruit key personnel would harm our ability to meet key objectives.
• Failure to manage our planned growth could harm our business.
• We operate in a highly competitive industry and face competition from large, well-established medical device manufacturers as well as new market entrants.
• Security breaches and other disruptions could compromise our information and expose us to liability, which would cause our business and reputation to suffer.
• We may not be able to maintain sufficient product liability insurance to cover claims against us.
• Competitors could invent products superior to ours and cause our products and technologies to become obsolete.
• We may have exposure to product liability claims.
• We may be found to infringe on intellectual property rights of others.
• Our business is affected by numerous regulations.
• If we fail to obtain or experience significant delays in obtaining regulatory clearances or approvals to market future medical device products, we will be unable to commercialize these products until such clearance or approval is obtained.
• Changes to the FDA clearance and approval processes or ongoing regulatory requirements could make it more difficult for us to obtain FDA clearance or, approval of new products or comply with ongoing requirements.
• Modifications to our current products may require new marketing clearances or approvals or require us to cease marketing or recall the modified products until such clearances or approvals are obtained.
• Changes in reimbursement policies and regulations by governmental or other third-party payers may have an adverse impact on the use of our products.
• We and our sales personnel, whether employed by us or by others, must comply with various federal and state anti-kickback, self-referral, false claims and similar laws, any breach of which could cause a material adverse effect on our business.
• The trading price of the shares of our common stock is highly volatile, and purchasers of our common stock could incur substantial losses.
• Our common stock does not have a vigorous trading market and you may not be able to sell your securities when desired.
• The potential sale of large amounts of common stock may have a negative effect upon the market value of our shares.
• We have not paid, and we are unlikely to pay cash dividends on our securities in the near future.
• A few of our existing shareholders own a large percentage of our voting stock and have control over matters requiring stockholder approval and may delay or prevent a change in control.
• Our Board can authorize the issuance of preferred stock, which could diminish the rights of holders of our common stock and make a change of control of the Company more difficult even if it might benefit our shareholders.